## Protocol Section
### Identification Module
**NCT ID:** NCT00363779

**Brief Title:** Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia

**Official Title:** Microarray Analysis of the Effect of Cyclosporine Therapy on Gene Expression Patterns in Large Granular Lymphocytic Leukemia

#### Organization Study ID Info
**ID:** 060177
#### Organization
**Class:** NIH
**Full Name:** National Institutes of Health Clinical Center (CC)
#### Secondary ID Infos
**ID:** 06-C-0177
### Status Module
#### Completion Date
**Date:** 2010-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-07-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-06-26

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2010-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-07-06

**Type:** ESTIMATED

**Results First Submit Date:** 2012-03-30

**Results First Submit QC Date:** 2012-05-29

#### Start Date
**Date:** 2006-06

**Status Verified Date:** 2015-06

#### Study First Post Date
**Date:** 2006-08-15
**Type:** ESTIMATED
**Study First Submit Date:** 2006-08-10
**Study First Submit QC Date:** 2006-08-10
**Why Stopped:** Study terminated due to low accrual and the investigator left the NIH.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Responsible Party

**Investigator Affiliation:** National Institutes of Health Clinical Center (CC)

**Investigator Full Name:** Thomas Waldmann, M.D.

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Background:

* Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkin's lymphoma.
* LGL is associated with low numbers of white blood cells (leading to recurring infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding).
* Cyclosporine (CSA) is an immunosuppressive drug that improves low blood cell counts in about 50 percent of patients with LGL leukemia.

Objectives:

* To identify what factors determine why cyclosporine works in some patients and not in others.
* To identify what causes low blood counts in LGL leukemia.

Eligibility: Patients 18 years of age and older with LGL leukemia.

Design:

* Patients have a medical history, physical examination blood tests, bone marrow biopsy and x-ray studies, including chest x-rays and computed tomography (CT) scans of the chest, abdomen and pelvis. Patients with an easily accessible enlarged lymph node have a node biopsy (removal of a small piece of tissue for microscopic examination).
* Patients take cyclosporine twice a day by mouth. Blood samples are taken at least weekly to adjust the cyclosporine dosing to maintain therapeutic serum levels.
* Patients undergo apheresis (collection of white blood cells) at a number of different time points in the study (maximum 6 times) to look at the differences in the leukemia cells before and during treatment with cyclosporine. For apheresis, blood is withdrawn through a needle in an arm vein and directed through a catheter (plastic tube) into a machine that separates it into its components. The white cells are extracted and the rest of the blood is returned through the same needle or through a second needle in the other arm.

**Detailed Description:** Background:

* LGL leukemia is a low grade non-Hodgkins Lymphoma characterized by tissue invasion of the marrow, spleen and liver
* Recurrent infections due to chronic neutropenia and transfusion-dependent anemia are the principal causes for initiation of therapy
* Approximately 50% of patients treated with cyclosporine (CSA) respond to treatment. CSA appears to correct the associated cytopenia without decreasing LGL numbers, suggesting it may inhibit LGL secretion of yet unidentified mediators of neutropenia and anemia.
* Analysis of differential gene expression profiles in patients with LGL leukemia treated with cyclosporine has the potential to detect as yet unidentified, therapeutic targets and possibly provide predictors of CSA responsiveness.

Objective:

* Identify changes in gene expression patterns induced by cyclosporine therapy in patients with LGL leukemia
* Identify differences between responding and non-responding patients

Eligibility:

-Patients with Large Granular Lymphocyte leukemia

Design:

* Patients will be treated with cyclosporine at a dose of 5-10mg/kg/day in divided doses, with doses adjusted to maintain a therapeutic serum level between 200-400ng/ml. These therapeutic levels shall be maintained for 3 months.
* Tumor response will be evaluated after 3 months therapy, the dose of CsA may then be tapered to that required to sustain a response or discontinued if no evidence of response, or after relapse.
* Blood sampling or Lymphapheresis for collection of circulating malignant cells will be performed at a number of different time points. Gene expression profiling will be carried out on Affymetrix microarrays to compare pretreatment and post-treatment samples.

### Conditions Module

**Conditions:**

- Large Granular Lymphocytic Leukemia

- LGL Leukemia

**Keywords:**

- Large Granular Lymphocyte (LGL)

- LGL

- Leukemia

- Cyclosporine

- Microarray

- Gene Expression

- Cyclosporin

- Large Granular Lymphocyte Leukemia

- LGL Leukemia

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 5

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.

**Intervention Names:**

- Drug: Cyclosporine

- Genetic: Gene expression analysis

- Genetic: Microarray analysis

- Other: Laboratory biomarker analysis

**Label:** LGL Patients administered cyclosporine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- LGL Patients administered cyclosporine

**Description:** An oral preparation given every 12 hours, 5-10 mg/kg/day in divided doses. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml. Levels will be checked twice weekly and once the patient has achieved steady state levels they shall be monitored once every 2 weeks. These therapeutic levels shall be maintained for 3 months.

**Name:** Cyclosporine

**Other Names:**

- Ciclosporin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- LGL Patients administered cyclosporine

**Description:** A permutation test will be performed to examine whether the overall expression profile changes due to treatment. This will be done by comparing the number of significant genes to the distribution of this number if in fact there is no difference between pre-treatment and post-treatment gene expression.

**Name:** Gene expression analysis

**Type:** GENETIC

#### Intervention 3

**Arm Group Labels:**

- LGL Patients administered cyclosporine

**Description:** Gene expression profiling will be carried out on Affymetrix microarrays to compare pretreatment and posttreatment samples.

**Name:** Microarray analysis

**Type:** GENETIC

#### Intervention 4

**Arm Group Labels:**

- LGL Patients administered cyclosporine

**Description:** Analysis of differential gene expression profiles in patients with LGL leukemia treated with cyclosporine.

**Name:** Laboratory biomarker analysis

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment.

**Measure:** Changes in Gene Expression Patterns

**Time Frame:** Baseline and 12 weeks

#### Secondary Outcomes

**Description:** Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

**Measure:** Number of Participants With Adverse Events

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** * INCLUSION CRITERIA:

  1. All patients must have a histologic or cytologic diagnosis of T-cell LGL leukemia as determined by the Laboratory of Pathology or Hematology at the Clinical Center, National Institutes of Health
  2. All patients must have hemocytopenias such as granulocyte count less than 1,200/ul, platelet count less than 100,000/ul or hemoglobin less than 10 g/dl, or require hematopoietic support (transfusion or colony stimulating factors) to maintain counts at these or higher levels.
  3. Patients must have measurable or evaluable disease
  4. Patients must have a creatinine of less than 2.0 mg/dl.
  5. Omission of cytotoxic chemotherapy for 3 weeks prior to entry into the trial is required. However, patients receiving stable corticosteroids will be eligible.
  6. Age greater than 18 years
  7. Karnofsky performance greater than 70%
  8. Patients must have a life expectancy of greater than 3 months.
  9. Patients must be able to understand and sign an Informed Consent form.
  10. All female patients must use adequate contraception during participation in this trial and for three months after completing therapy.

EXCLUSION CRITERIA:

1. Patients with uncontrolled hypertension
2. Pregnant and nursing patients are not eligible for the study as CSA crosses the placenta. Based on clinical use, premature births and low birth weight were consistently observed. Breast-feeding is contraindicated because CSA enters the blood milk and may possibly be administered to the child.
3. Underlying immunodeficiency state including human immunodeficiency virus (HIV) seropositivity.
4. Positive for antibodies to hepatitis C or positive for hepatitis B surface antigen,
5. Patients with serious intercurrent illnesses, concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious or metabolic disease of such severity that it would preclude the patients' ability to tolerate cyclosporine.
6. Patients who received cyclosporine for LGL leukemia previously and failed to respond.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bethesda

**Country:** United States

**Facility:** National Institutes of Health Clinical Center, 9000 Rockville Pike

**State:** Maryland

**Zip:** 20892

#### Overall Officials

**Official 1:**

**Affiliation:** National Cancer Institute, National Institutes of Health

**Name:** Thomas Waldmann, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Lamy T, Loughran TP Jr. Clinical features of large granular lymphocyte leukemia. Semin Hematol. 2003 Jul;40(3):185-95. doi: 10.1016/s0037-1963(03)00133-1.

**PMID:** 12876667

**Citation:** Vie H, Chevalier S, Garand R, Moisan JP, Praloran V, Devilder MC, Moreau JF, Soulillou JP. Clonal expansion of lymphocytes bearing the gamma delta T-cell receptor in a patient with large granular lymphocyte disorder. Blood. 1989 Jul;74(1):285-90.

**PMID:** 2546620

**Citation:** Lamy T, Dauriac C, Le Prise PY. Long-term survival in chronic granulocytic leukaemia. Br J Haematol. 1989 Oct;73(2):279. doi: 10.1111/j.1365-2141.1989.tb00270.x. No abstract available.

**PMID:** 2818949

#### See Also Links

**Label:** Genetics Home Reference

**URL:** http://ghr.nlm.nih.gov/

**Label:** Medline Plus

**URL:** http://www.nlm.nih.gov/medlineplus/

**Label:** Drug Information

**URL:** http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp

**Label:** US FDA Resources

**URL:** http://www.clinicaltrials.gov/ct2/info/fdalinks

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000015458

- Term: Leukemia, T-Cell

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M10951

- Name: Leukemia, Lymphoid

- Relevance: HIGH

- As Found: Lymphocytic Leukemia

- ID: M27552

- Name: Leukemia, Large Granular Lymphocytic

- Relevance: HIGH

- As Found: Large Granular Lymphocytic Leukemia

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18119

- Name: Leukemia, T-Cell

- Relevance: LOW

- As Found: Unknown

- ID: T238

- Name: Aggressive NK Cell Leukemia

- Relevance: HIGH

- As Found: Large Granular Lymphocytic Leukemia

- ID: T5568

- Name: T-cell Large Granular Lymphocyte Leukemia

- Relevance: HIGH

- As Found: Large Granular Lymphocytic Leukemia

### Condition Browse Module - Meshes

- ID: D000007938

- Term: Leukemia

- ID: D000007945

- Term: Leukemia, Lymphoid

- ID: D000054066

- Term: Leukemia, Large Granular Lymphocytic

### Intervention Browse Module - Ancestors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000935

- Term: Antifungal Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000003879

- Term: Dermatologic Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000065095

- Term: Calcineurin Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M18961

- Name: Cyclosporine

- Relevance: HIGH

- As Found: New

- ID: M6730

- Name: Cyclosporins

- Relevance: HIGH

- As Found: New

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M6252

- Name: Clotrimazole

- Relevance: LOW

- As Found: Unknown

- ID: M11796

- Name: Miconazole

- Relevance: LOW

- As Found: Unknown

- ID: M4254

- Name: Antifungal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M30452

- Name: Calcineurin Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016572

- Term: Cyclosporine

- ID: D000003524

- Term: Cyclosporins

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** LGL Patients Administered Cyclosporine

**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.

**ID:** EG000

**Other Num Affected:** 5

**Other Num at Risk:** 5

**Serious Number Affected:** 2

**Serious Number At Risk:** 5

**Title:** LGL Patients Administered Cyclosporine

**Frequency Threshold:** 0

#### Other Events

**Term:** ALT, SGPT (serum glutamic pyruvic transaminase)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTC3.0

**Term:** AST, SGOT(serum glutamic oxaloacetic transaminase)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTC3.0

**Term:** Albumin, serum-low (hypoalbuminemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTC3.0

**Term:** Alkaline phosphatase

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTC3.0

**Term:** Bicarbonate, serum-low

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTC3.0

**Term:** Bilirubin (hyperbilirubinemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTC3.0

**Term:** Calcium, serum-low (hypocalcemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTC3.0

**Term:** Cholesterol, serum-high (hypercholesteremia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTC3.0

**Term:** Creatinine

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTC3.0

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTC3.0

**Term:** Glucose, serum-high (hyperglycemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTC3.0

**Term:** Hemoglobin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTC3.0

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTC3.0

**Term:** Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTC3.0

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTC3.0

**Term:** Leukocytes (total WBC)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTC3.0

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTC3.0

**Term:** Magnesium, serum-low (hypomagnesemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTC3.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTC3.0

**Term:** Neutrophils/granulocytes (ANC/AGC)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTC3.0

**Term:** Pain::Bone

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTC3.0

**Term:** Pain::Head/headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTC3.0

**Term:** Pain::Muscle

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** CTC3.0

**Term:** Phosphate, serum-low (hypophosphatemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTC3.0

**Term:** Platelets

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTC3.0

**Term:** Potassium, serum-high (hyperkalemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTC3.0

**Term:** Potassium, serum-low (hypokalemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTC3.0

**Term:** Rash: acne/acneiform

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTC3.0

**Term:** Sodium, serum-low (hyponatremia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTC3.0

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTC3.0

**Term:** Triglyceride, serum-high (hypertriglyceridemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTC3.0

**Term:** Uric acid, serum-high (hyperuricemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTC3.0

#### Serious Events

**Term:** Infection with normal ANC or Grade 1 or 2 neutrophils-Lung (pneumonia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTC3.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 5

**Num Events:** 1

**Term:** Second malignancy-possibly related to cancer treatment (Specify) new abdominal mass

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** CTC3.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 5

**Num Events:** 1

**Time Frame:** 3 yrs, 10 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 5

**Units:** Participants

### Group

**ID:** BG000

**Title:** LGL Patients Administered Cyclosporine

**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 3

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.09

**Value:** 67.7

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 5

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 5

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** As there were only 5 patients treated, the primary endpoints of this protocol were not met and there is not enough data generated for statistical analysis. This protocol is being terminated due to low accrual and the investigator leaving the NIH.
### Point of Contact
**Email:** Thomas_Waldmann@nih.gov
**Organization:** National Cancer Institute (NCI), National Institutes of Health (NIH)
**Phone:** 301-496-6653
**Title:** Thomas Waldmann, M.D.
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment.
**Population Description:** This outcome measure was not performed because there were insufficient data points to provide any statistical power.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 12 weeks
**Title:** Changes in Gene Expression Patterns
**Type:** PRIMARY
##### Group
**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
**ID:** OG000
**Title:** LGL Patients Administered Cyclosporine
#### Outcome Measure 2
**Description:** Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 3 months
**Title:** Number of Participants With Adverse Events
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
**ID:** OG000
**Title:** LGL Patients Administered Cyclosporine
### Participant Flow Module
#### Group
**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
**ID:** FG000
**Title:** LGL Patients Administered Cyclosporine
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True