## Protocol Section
### Identification Module
**NCT ID:** NCT01698879

**Brief Title:** Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment

**Official Title:** Treatment of de Novo Acute Myeloid Leukemia With the Combination of Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin (Mylotarg ®), Associated or Not Priming With G-CSF. Prospective Study of Efficacy and Toxicity

#### Organization Study ID Info
**ID:** ICOG-07
#### Organization
**Class:** OTHER
**Full Name:** Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
#### Secondary ID Infos
**ID:** 2007-006295-11
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2016-09-26

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-01-27

**Type:** ACTUAL

**Last Update Submit Date:** 2021-01-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-09-14

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-01-27

**Type:** ACTUAL

**Results First Submit Date:** 2017-02-13

**Results First Submit QC Date:** 2021-01-26

#### Start Date
**Date:** 2009-10

**Status Verified Date:** 2021-01

#### Study First Post Date
**Date:** 2012-10-03
**Type:** ESTIMATED
**Study First Submit Date:** 2012-07-23
**Study First Submit QC Date:** 2012-10-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Acute myeloid leukemia (AML) is a neoplasm of immature hematopoietic cells (blasts) with altered ripening capacity. Due to excessive proliferation, the blasts displace normal hematopoietic cells and bone marrow failure appears. Leukemic cells also infiltrate extramedullary tissues.

Following the standard chemotherapy treatment, the CR rate achieved is around 65-75% for all patients and 15% lower when considering only patients over 65 years. Modifications to the standard regimen consist of replacing the DNR for a cytotoxic one, modifying the dose of ara-C or adding a third drug.

Gemtuzumab ozogamicin (Mylotarg ®) is an immunoconjugate between anti-CD33 antibody and a cytotoxic antitumor antibiotic, calicheamicin. Mylotarg ® antibody specifically binds to CD33, a sialic acid-dependent adhesion protein expressed in over 90% of LMA10. Mylotarg ® selectively transports the cytotoxic agent calicheamicin into leukemic cells and hematopoietic progenitors differentiated from the myelomonocytic line, while respecting the pluripotent hematopoietic stem cells. Calicheamicin is released only after the fixation of the antibody anti-CD33 and its internalization by the cell, after which binds to and damages the DNA.

Mylotarg ® is approved in the U.S. for the treatment of CD33 positive AML in first relapse, for patients older than 60 years non-candidates for other intensive treatment modalities.

Since the efficacy of Mylotarg ® is equivalent and its toxicity profile less than the conventional therapy, it is logical to conduct a phase II trial exploring the role of Mylotarg ® in the early stages of treatment of AML.

Previous experience with gemtuzumab ozogamicin in relapsed patients led to its use combined with induction chemotherapy. The aim was to improve the CR rate reached with the latter and reduce relapse after achieving greater leukemic cytoreduction.

Recent data from the HOVON group support that the administration of G-CSF before and during induction chemotherapy decreases the incidence of relapse in patients with AML, particularly those considered to have intermediate risk.

Everything mentioned above justifies to investigate the combination of GO combined with chemotherapy with IDR and ara-C in standard 3x7 scheme and analyze the effect of sensitization with G-CSF in patients with AML de novo. If the treatment proposed here is effective and presents an acceptable toxicity it should be investigated.

### Conditions Module

**Conditions:**

- Novo Acute Myeloid Leukemia

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 46

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Idarubicin, cytarabine, Mylotarg.

**Intervention Names:**

- Drug: Mylotarg

**Label:** Single arm, three cohorts

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Single arm, three cohorts

**Description:** Cohort 1 version 1.0. GO: 6mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine: 100 mg/m\^2 IV days 1 to 7, to begin 4 hours after the administration of GO.

Cohort 1.0 version 2.0: GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine: 100 mg/m\^2 IV days 1 to 7, to begin 4 hours after the administration of GO.

Cohort 2: G-CSF: 150 mcg/m\^2, SC, days 0 to 7. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine: 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.

**Name:** Mylotarg

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Rate of patients that have obtained complete remission. Complete remission is defined as, bone marrow normocellular or slightly hypocellular with proportion of blasts \<5%, including the erythroid cell count (and including promonocytes in case of M5), no Auer rods, no extramedullary leukemia, neutrophils and platelets rising. The persistence of minimal residual disease in immunophenotypic study will not invalidate the standard cytogenetic complete remission.

**Measure:** Complete Remission of the Disease

**Time Frame:** 28 days after chemotherapy

#### Secondary Outcomes

**Description:** Hematological toxicity, hepatic and gastrointestinal toxicity, fever and infections, pulmonary complications, duration of hospitalization

**Measure:** Secondary Toxicity to Mylotarg(R)

**Time Frame:** Baseline, weekly during treatment and at month 3 and month 6 after first induction.

**Description:** all deaths occurring after the first administration of MylotargTM until the time of transplantation with no leukemic relapse has occurred, and all deaths in the 6 first months after administration of the second dose of MylotargTM with no leukemic relapse occurred.

**Measure:** Mortality at Induction

**Time Frame:** Weekly during treatment, at third month and at 6 months after last administration of Mylotarg

**Description:** Rate of patients with capacity to obtain hematopoietic progenitor cells (HPC) for autotransplantation. This analysis has not been performed, because data were not available in sites.

**Measure:** Capacity to Obtain Hematopoietic Progenitor Cells (HPC) for Autotransplantation - DATA NOT COLLECTED

**Time Frame:** One month before transplant, expected at 9 months after end of treatment.

**Description:** Rate of patients that have relapse after 6 months of obtained complete remission.

**Measure:** Relapse After 6 Months

**Time Frame:** 6 months from complete remission

**Description:** rate of patients alive within 6 months of obtained complete remission

**Measure:** Survival After 6 Months

**Time Frame:** 6 months after complete remission

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patients with primary or "de novo" AML, different than promyelocytic or M3 subtype.
2. Age 18 to 70 years.
3. Written informed consent form

Exclusion Criteria:

1. Acute leukemia appeared after a myeloproliferative process or a myelodysplastic syndrome longer than 6 months, AML arising after another cured malignant disease (e.g. Hodgkin's disease), and secondary AML treated with alkylating agents or radiation.
2. Acute promyelocytic leukemia.
3. Relevant history of liver disease. Significant impaired liver function (bilirubin, AST or ALT ≥ 2.5 times the normal value) not attributable to leukemic infiltration.
4. Patients with prior heart failure.
5. Symptomatic chronic respiratory failure.
6. Positive serology for HIV, hepatitis C virus or its surface antigen.
7. Estimated life expectancy less than 3 months, despite treatment.
8. Pregnancy or breastfeeding at the time of inclusion in the study.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Badalona

**Country:** Spain

**Facility:** Hospital Germans Trias i Pujol

**State:** Barcelona

**Zip:** 08916

**Location 2:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital de la Santa Creu i Sant Pau

**Zip:** 08025

**Location 3:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Clinic Barcelona

**Zip:** 08036

**Location 4:**

**City:** Salamanca

**Country:** Spain

**Facility:** Hospital Clinico Universitario de Salamanca

**Zip:** 37007

**Location 5:**

**City:** Sevilla

**Country:** Spain

**Facility:** Hospital Universitario Virgen del Rocio

**Zip:** 41013

**Location 6:**

**City:** Valencia

**Country:** Spain

**Facility:** Hospital Clínico Universitario de Valencia

**Zip:** 496010

#### Overall Officials

**Official 1:**

**Affiliation:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

**Name:** Jordi Sierra, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M10955

- Name: Leukemia, Myeloid

- Relevance: HIGH

- As Found: Myeloid Leukemia

- ID: M18127

- Name: Leukemia, Myeloid, Acute

- Relevance: HIGH

- As Found: Acute Myeloid Leukemia

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3995

- Name: Myeloid Leukemia

- Relevance: HIGH

- As Found: Myeloid Leukemia

- ID: T182

- Name: Acute Myeloid Leukemia

- Relevance: HIGH

- As Found: Acute Myeloid Leukemia

- ID: T188

- Name: Acute Non Lymphoblastic Leukemia

- Relevance: HIGH

- As Found: Acute Myeloid Leukemia

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007938

- Term: Leukemia

- ID: D000007951

- Term: Leukemia, Myeloid

- ID: D000015470

- Term: Leukemia, Myeloid, Acute

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000922

- Term: Immunotoxins

- ID: D000018796

- Term: Immunoconjugates

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6766

- Name: Cytarabine

- Relevance: LOW

- As Found: Unknown

- ID: M17958

- Name: Idarubicin

- Relevance: LOW

- As Found: Unknown

- ID: M2089

- Name: Gemtuzumab

- Relevance: HIGH

- As Found: Yes

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M4241

- Name: Immunotoxins

- Relevance: LOW

- As Found: Unknown

- ID: M20855

- Name: Immunoconjugates

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000079982

- Term: Gemtuzumab

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Cohort 1

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 20

**Description:** Idarubicin, cytarabine, Mylotarg, G-CSF.

Mylotarg: Cohort 1 (20 evaluable patients):

GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.

**ID:** EG000

**Other Num Affected:** 20

**Other Num at Risk:** 20

**Serious Number Affected:** 3

**Serious Number At Risk:** 20

**Title:** Cohort 1

**Group ID:** EG001

**Title:** Cohort 2

**Deaths Num Affected:** 2

**Deaths Num At Risk:** 20

**Description:** Cohort 2 (20 evaluable patients):

G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.

Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.

**ID:** EG001

**Other Num Affected:** 19

**Other Num at Risk:** 20

**Serious Number Affected:** 6

**Serious Number At Risk:** 20

**Title:** Cohort 2

**Group ID:** EG002

**Title:** 5 Patients Treated in Trial With Prrotocol Version 1.0

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 5

**Description:** Idarubicin, cytarabine, Mylotarg, G-CSF.

Mylotarg::

GO: 5 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. If no adequate response, GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.

Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.

**ID:** EG002

**Other Num Affected:** 3

**Other Num at Risk:** 5

**Serious Number Affected:** 2

**Serious Number At Risk:** 5

**Title:** 5 Patients Treated in Trial With Prrotocol Version 1.0

**Frequency Threshold:** 5

#### Other Events

**Term:** Grade 4 hematologic toxicity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** G1/2 Hepatic toxicity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** 

**Term:** G3/G4 Hepatic Toxicity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** 

**Term:** Grade I/II infectous toxicity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Grade 3 Infectous toxicity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

#### Serious Events

**Term:** Transient Ischemic event

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 20

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 5

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 20

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 5

**Term:** Severe respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 20

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 20

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 5

**Term:** Toxic megacolon

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 20

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 5

**Term:** Bilateral pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 20

**Group ID:** EG002

**Num At Risk:** 5

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 20

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 5

**Term:** Anemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 20

**Group ID:** EG002

**Num At Risk:** 5

**Term:** Liver failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 20

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 5

**Term:** Hepatic Toxicity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 20

**Group ID:** EG001

**Num At Risk:** 20

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 5

**Num Events:** 2

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 20

**Group ID:** EG002

**Num At Risk:** 5

**Term:** Acute Pulmonary Edema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 20

**Group ID:** EG002

**Num At Risk:** 5

**Time Frame:** From October 2008 up to September 2016, 7 years and 11 months.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 5

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 20

**Group ID:** BG003

**Value:** 45

**Units:** Participants

### Group

**ID:** BG000

**Title:** Cohort 1, Version 1.0

**Description:** Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):

GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.

If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.

### Group

**ID:** BG001

**Title:** Cohort 1, Version 2.0

**Description:** Mylotarg: Cohort 1 (20 evaluable patients):

GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4.

Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.

### Group

**ID:** BG002

**Title:** Cohort 2

**Description:** Cohort 2 (20 evaluable patients):

G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.

Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 32

**Upper Limit:** 61

**Value:** 56

#### Measurement

**Group ID:** BG001

**Lower Limit:** 22

**Upper Limit:** 64

**Value:** 49

#### Measurement

**Group ID:** BG002

**Lower Limit:** 24

**Upper Limit:** 69

**Value:** 61

#### Measurement

**Group ID:** BG003

**Lower Limit:** 22

**Upper Limit:** 69

**Value:** 61

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 16

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 15

#### Measurement

**Group ID:** BG003

**Value:** 29

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 20

#### Measurement

**Group ID:** BG003

**Value:** 45

**Class Title:** Spain

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 2.1

**Upper Limit:** 31.85

**Value:** 13.48

#### Measurement

**Group ID:** BG001

**Lower Limit:** 1

**Upper Limit:** 96.6

**Value:** 7.66

#### Measurement

**Group ID:** BG002

**Lower Limit:** 0.9

**Upper Limit:** 114

**Value:** 6.96

#### Measurement

**Group ID:** BG003

**Lower Limit:** 0.9

**Upper Limit:** 114

**Value:** 6.96

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 9

**Category Title:** Favorable

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 12

#### Measurement

**Group ID:** BG003

**Value:** 28

**Category Title:** Intermediate

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 8

**Category Title:** Adverse

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Population Description:** One patient has not been evaluated because has not received study treatment.
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 4
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Population Description:** The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming.
**Title:** Leucocites at diagnosis
**Unit of Measure:** Cells x 10^9/L
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 1 patient not evaluable because has not received study treatment.
**Title:** Citogenetic
**Unit of Measure:** Participants
**Population Description:** From cohort 1 version 1.0, one patient did not receive any study treatment (PIS withdrawal), for that reason is not considered for outcome assessment.
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Email:** jsierra@santpau.cat
**Organization:** CETLAM
**Phone:** +34 93 434 44 12
**Title:** Dr. Jordi Sierra
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** It has not been evaluated efficacy result of this cohort with unacceptable toxicity profile
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** Complete Response
##### Category
**Measurements:**
- **Comment:** It has not been evaluated efficacy result of this cohort with unacceptable toxicity profile
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** Partial Response
##### Category
**Measurements:**
- **Comment:** It has not been evaluated efficacy result of this cohort with unacceptable toxicity profile
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** NA
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** Refractory
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 4
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Rate of patients that have obtained complete remission. Complete remission is defined as, bone marrow normocellular or slightly hypocellular with proportion of blasts \<5%, including the erythroid cell count (and including promonocytes in case of M5), no Auer rods, no extramedullary leukemia, neutrophils and platelets rising. The persistence of minimal residual disease in immunophenotypic study will not invalidate the standard cytogenetic complete remission.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible.
**Reporting Status:** POSTED
**Time Frame:** 28 days after chemotherapy
**Title:** Complete Remission of the Disease
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):

GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.

If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
**ID:** OG000
**Title:** Cohort 1, Version 1.0
##### Group
**Description:** Mylotarg: Cohort 1 (20 evaluable patients):

GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG001
**Title:** Cohort 1, Version 2.0
##### Group
**Description:** Cohort 2 (20 evaluable patients):

G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.

Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG002
**Title:** Cohort 2
#### Outcome Measure 2
**Description:** Hematological toxicity, hepatic and gastrointestinal toxicity, fever and infections, pulmonary complications, duration of hospitalization
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Baseline, weekly during treatment and at month 3 and month 6 after first induction.
**Title:** Secondary Toxicity to Mylotarg(R)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Initial 5 patients of cohort 1 (closed due toxicity)
**ID:** OG000
**Title:** Cohort 1, Version 1.0
##### Group
**Description:** Idarubicin, cytarabine, Mylotarg

Mylotarg: Cohort 1 (20 evaluable patients):

GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG001
**Title:** Cohort 1, Version 2.0
##### Group
**Description:** Cohort 2 (20 evaluable patients):

G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.

Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG002
**Title:** Cohort 2
#### Outcome Measure 3
**Description:** all deaths occurring after the first administration of MylotargTM until the time of transplantation with no leukemic relapse has occurred, and all deaths in the 6 first months after administration of the second dose of MylotargTM with no leukemic relapse occurred.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** Weekly during treatment, at third month and at 6 months after last administration of Mylotarg
**Title:** Mortality at Induction
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Initial 5 patients of cohort 1 (closed due toxicity)
**ID:** OG000
**Title:** Cohort 1, Version 1.0
##### Group
**Description:** Mylotarg: Cohort 1 (20 evaluable patients):

GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG001
**Title:** Cohort 1 Version 2.0
##### Group
**Description:** Cohort 2 (20 evaluable patients):

G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.

Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG002
**Title:** Cohort 2
#### Outcome Measure 4
**Description:** Rate of patients with capacity to obtain hematopoietic progenitor cells (HPC) for autotransplantation. This analysis has not been performed, because data were not available in sites.
**Population Description:** Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible. This analysis has not been performed because data were not available for any of the cohorts studied.
**Reporting Status:** POSTED
**Time Frame:** One month before transplant, expected at 9 months after end of treatment.
**Title:** Capacity to Obtain Hematopoietic Progenitor Cells (HPC) for Autotransplantation - DATA NOT COLLECTED
**Type:** SECONDARY
##### Group
**Description:** Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):

GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.

If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
**ID:** OG000
**Title:** Cohort 1, Version 1.0
##### Group
**Description:** Idarubicin, cytarabine, Mylotarg

Mylotarg: Cohort 1 (20 evaluable patients):

GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG001
**Title:** Cohort 1, Version 2.0
##### Group
**Description:** Cohort 2 (20 evaluable patients):

G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.

Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG002
**Title:** Cohort 2
#### Outcome Measure 5
**Description:** Rate of patients that have relapse after 6 months of obtained complete remission.
**Parameter Type:** NUMBER
**Population Description:** Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible.
**Reporting Status:** POSTED
**Time Frame:** 6 months from complete remission
**Title:** Relapse After 6 Months
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Idarubicin, cytarabine, Mylotarg.

Mylotarg: Cohort 1 (20 evaluable patients):

GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG000
**Title:** Cohort 1, Version 2.0
##### Group
**Description:** Cohort 2 (20 evaluable patients):

G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.

Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG001
**Title:** Cohort 2
#### Outcome Measure 6
**Description:** rate of patients alive within 6 months of obtained complete remission
**Parameter Type:** NUMBER
**Population Description:** Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible.
**Reporting Status:** POSTED
**Time Frame:** 6 months after complete remission
**Title:** Survival After 6 Months
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Idarubicin, cytarabine, Mylotarg, G-CSF.

Mylotarg: Cohort 1 (20 evaluable patients):

GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG000
**Title:** Cohort 1
##### Group
**Description:** Cohort 2 (20 evaluable patients):

G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.

Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG001
**Title:** Cohort 2
### Participant Flow Module
#### Group
**Description:** Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):

GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.

If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
**ID:** FG000
**Title:** Cohort 1 Version 1.0
#### Group
**Description:** Idarubicin, cytarabine, Mylotarg

Mylotarg: Cohort 1 (20 evaluable patients):

GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** FG001
**Title:** Cohort 1 Version 2.0
#### Group
**Description:** Cohort 2 (20 evaluable patients):

G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.

Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** FG002
**Title:** Cohort 2
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 20
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
**Has Results:** True