Methotrexate Followed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia

German CLL Study Group

Status and phase: Terminated; Phase 2

Conditions: T-Cell Large Granular Lymphocytic Leukemia

Treatments: Drug: MTX followed by fludarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00278265

EU-20564

GCLLSG-LGL1

LGL1

CDR0000454596 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as methotrexate and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well methotrexate works as first-line therapy and fludarabine works as second-line therapy in treating patients with T-cell large granular lymphocytic leukemia.

Full description

OBJECTIVES:

Primary

• Determine remission rates and duration of remission in patients with T-cell large granular lymphocytic (T-LGL) leukemia needing intervention because of anemia or neutropenia and are treated with parenteral methotrexate (MTX) as first-line therapy
• Determine remission rate and duration of remission in patients who fail to respond to MTX therapy and are subsequently treated with fludarabine as second-line therapy.

Secondary

• Determine the side effects of these drugs in these patients.
• Determine the rate of molecular remissions in patients treated with these drugs.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive methotrexate subcutaneously once weekly in the absence of disease progression or unacceptable toxicity. Patients not achieving a response to methotrexate receive fludarabine IV on days 1-3. Treatment with fludarabine repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of T-cell large granular lymphocytic (T-LGL) leukemia
• Must have concurrent anemia or neutropenia

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 2 years
• Not pregnant
• Fertile patients must use effective contraception
• No other malignancy
• No active infection

PRIOR CONCURRENT THERAPY:

• No prior immunosuppressive treatment
• No previous treatment with methotrexate or fludarabine

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

MTX followed by fludarabine

Experimental group

Description:

MTX is given with a dose of 10-20mg weekly Fludarabine is dosed with 25mg/m2 day 1-3 of 28 days, up to 4 cycles

Treatment:

Drug: MTX followed by fludarabine