## Protocol Section
### Identification Module
**NCT ID:** NCT00766779

**Brief Title:** HCT Versus CT in Elderly AML

**Official Title:** Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission

#### Organization Study ID Info
**ID:** 2007-003514-34
#### Organization
**Class:** NETWORK
**Full Name:** European Society for Blood and Marrow Transplantation
#### Secondary ID Infos
**ID:** EBMT-ALWP01/2008
### Status Module
#### Completion Date
**Date:** 2020-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-10-14

**Type:** ACTUAL

**Last Update Submit Date:** 2021-10-06

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2020-12

**Type:** ACTUAL

#### Start Date
**Date:** 2010-01

**Status Verified Date:** 2021-10

#### Study First Post Date
**Date:** 2008-10-06
**Type:** ESTIMATED
**Study First Submit Date:** 2008-10-03
**Study First Submit QC Date:** 2008-10-03
**Why Stopped:** Recommendation of DMC
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Acute Leukemia French Association

**Class:** OTHER

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

**Class:** NETWORK

**Name:** European Organisation for Research and Treatment of Cancer - EORTC

**Class:** OTHER

**Name:** French Innovative Leukemia Organisation

**Class:** OTHER

**Name:** HOVON - Dutch Haemato-Oncology Association

**Class:** UNKNOWN

**Name:** East German Study Group of Hematology and Oncology (OSHO)

**Class:** OTHER

**Name:** Swiss Group for Clinical Cancer Research

#### Lead Sponsor

**Class:** NETWORK

**Name:** European Society for Blood and Marrow Transplantation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

**Detailed Description:** The majority of patients with acute myelogenous leukaemia (AML) enter complete remission following induction therapy, but relapse despite consolidation and maintenance therapy. In response, post-remission treatment has been progressively intensified and results improved either by high-dose post-remission therapy with autologous hematopoietic cell transplantation (HCT) or by allogeneic HCT, which has the highest curative potential for patients with AML. Given the toxicity of dose intensification and of allogeneic HCT, however, only younger patients profit from this treatment approach

### Conditions Module

**Conditions:**

- Acute Myeloid Leukemia

**Keywords:**

- hematopoietic cell transplantation

- Acute Myeloid Leukemia

- first Complete Remission

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 126

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Hematopoietic cell transplantation after Reduced Intensity Conditioning

**Intervention Names:**

- Procedure: hematopoietic cell transplantation

**Label:** Transplant Arm

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The non-transplant treatment approach for consolidation

**Intervention Names:**

- Drug: Non-Transplant treatment approach for consolidation

**Label:** Conventional Chemotherapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Transplant Arm

**Description:** low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors

**Name:** hematopoietic cell transplantation

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Conventional Chemotherapy

**Description:** Patients will receive the treatment that would be otherwise applied at the local institution. The consolidation or maintenance therapy is according to the study group protocol.

**Name:** Non-Transplant treatment approach for consolidation

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy

**Time Frame:** 5 years

#### Secondary Outcomes

**Measure:** To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT

**Time Frame:** 5 Years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥ 60years and ≤ 75 years
* primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
* First complete remission following one or two cycles of induction chemotherapy
* Chemotherapy was administered according to current participating cooperative group protocols
* Karnofsky score ≥ 70
* Written informed consent

Exclusion Criteria:

* AML FAB M3
* HIV positivity
* Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if

  * The second study exclusively concerns induction therapy
  * Consolidation cycle one and two are given according to the accredited study group policy
  * No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
  * Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted

**Maximum Age:** 75 Years

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Melbourne Victoria

**Country:** Australia

**Facility:** The Alfred Hospital

**Location 2:**

**City:** Wien

**Country:** Austria

**Facility:** Hanusch Krankenhaus der Wiener Gebietskrankenkasse

**Location 3:**

**City:** Wien

**Country:** Austria

**Facility:** Medizinische Universität Wien

**Location 4:**

**City:** Antwerpen

**Country:** Belgium

**Facility:** ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen

**Location 5:**

**City:** Leuven

**Country:** Belgium

**Facility:** UZ Gasthuisberg Leuven

**Location 6:**

**City:** Amiens cedex 1

**Country:** France

**Facility:** Centre Hospitalier Sud Amiens

**Location 7:**

**City:** Caen Cedex 9

**Country:** France

**Facility:** Hopital Femme Enfant Hématologie

**Location 8:**

**City:** Clamart

**Country:** France

**Facility:** Hôpital d'instruction des armées Percy

**Location 9:**

**City:** Clermont-Ferrand

**Country:** France

**Facility:** Centre hospitalier et universitaire (CHU) d´ Estaing

**Location 10:**

**City:** Limoges cedex

**Country:** France

**Facility:** Centre hospitalier et universitaire (CHU) de Limoges

**Location 11:**

**City:** Marseille cedex 9

**Country:** France

**Facility:** Institut Paoli-Calmettes

**Location 12:**

**City:** Nantes cedex 01

**Country:** France

**Facility:** CHU de Nantes, Hôtel Dieu

**Location 13:**

**City:** Nice cedex 2

**Country:** France

**Facility:** Centre Antoine Lacassagne

**Location 14:**

**City:** Nice

**Country:** France

**Facility:** Centre hospitalier et universitaire (CHU) de Nice

**Location 15:**

**City:** Paris 12ème

**Country:** France

**Facility:** Hopital Saint Antoine

**Location 16:**

**City:** Pessac

**Country:** France

**Facility:** CHU du Haut Lévêque

**Location 17:**

**City:** Saint Quentin cedex

**Country:** France

**Facility:** Centre Hospitalier (CH) Saint Quentin

**Location 18:**

**City:** Aachen

**Country:** Germany

**Facility:** University Aachen

**Location 19:**

**City:** Augsburg

**Country:** Germany

**Facility:** II. Medizinische Klinik, Hämatologie/Internistische Onkologie

**Location 20:**

**City:** Berlin

**Country:** Germany

**Facility:** Charité - Campus Benjamin Franklin

**Location 21:**

**City:** Chemnitz

**Country:** Germany

**Facility:** Klinikum Chemnitz gGmbH

**Location 22:**

**City:** Dresden

**Country:** Germany

**Facility:** Universitaetsklinikum Dresden

**Location 23:**

**City:** Greifswald

**Country:** Germany

**Facility:** Klinik für Innere Medizin C

**Location 24:**

**City:** Heidelberg

**Country:** Germany

**Facility:** University of Heidelberg

**Location 25:**

**City:** Jena

**Country:** Germany

**Facility:** Friedrich-Schiller-Universität Jena

**Location 26:**

**City:** Leipzig

**Country:** Germany

**Facility:** University Hospital

**Zip:** 04103

**Location 27:**

**City:** Magdeburg

**Country:** Germany

**Facility:** Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität

**Location 28:**

**City:** Münster

**Country:** Germany

**Facility:** University of Münster

**Location 29:**

**City:** Potsdam

**Country:** Germany

**Facility:** Klinikum Ernst von Bergmann gGmbH

**Location 30:**

**City:** Regensburg

**Country:** Germany

**Facility:** University Regensburg

**Location 31:**

**City:** Rostock

**Country:** Germany

**Facility:** Universität Rostock

**Location 32:**

**City:** Stuttgart

**Country:** Germany

**Facility:** Robert-Bosch-Krankenhaus

**Location 33:**

**City:** Tübingen

**Country:** Germany

**Facility:** Universität Tübingen

**Location 34:**

**City:** Würzburg

**Country:** Germany

**Facility:** Allogeneic Stem Cell Transplant Cente

**Location 35:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Academisch Ziekenhuis bij de Universiteit Amsterdam

**Location 36:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** VU University Medical Center Amsterdam

**Location 37:**

**City:** Groningen

**Country:** Netherlands

**Facility:** University Medical Centre Groningen

**Location 38:**

**City:** Maastricht

**Country:** Netherlands

**Facility:** University Hospital Maastricht

**Location 39:**

**City:** Rotterdam

**Country:** Netherlands

**Facility:** Erasmus MC-Daniel den Hoed Cancer Centre

**Zip:** 3008

**Location 40:**

**City:** Utrecht

**Country:** Netherlands

**Facility:** University Medical Centre Utrecht

**Location 41:**

**City:** Zwolle

**Country:** Netherlands

**Facility:** Isala klinieken

**Location 42:**

**City:** Aarau

**Country:** Switzerland

**Facility:** Kantonsspital Aarau

**Location 43:**

**City:** Basel

**Country:** Switzerland

**Facility:** University Hospital

**Zip:** 4031

**Location 44:**

**City:** Bern

**Country:** Switzerland

**Facility:** Inselspital Bern

**Location 45:**

**City:** Geneve

**Country:** Switzerland

**Facility:** Hopitaux Universitaires de Geneve

**Zip:** 1211

**Location 46:**

**City:** Lausanne

**Country:** Switzerland

**Facility:** CHUV Lausanne

**Location 47:**

**City:** Luzern 16

**Country:** Switzerland

**Facility:** Kantonsspital Luzern

**Location 48:**

**City:** Zürich

**Country:** Switzerland

**Facility:** University Hospital Zürich

#### Overall Officials

**Official 1:**

**Affiliation:** EBMT and OSHO

**Name:** Dietger Niederwieser, Prof

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Stichting Hemato-Oncologie voor Volwassenen Nederland

**Name:** Bob Löwenberg, Prof

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007938

- Term: Leukemia

- 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: LOW

- As Found: Unknown

- 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: D000007951

- Term: Leukemia, Myeloid

- ID: D000015470

- Term: Leukemia, Myeloid, Acute

### Misc Info Module

#### Removed Countries

- Country: Italy

- Country: Spain

- Version Holder: 2024-05-24
