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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia

NCT00278213

Prolymphocytic Leukemia

COMPLETED PHASE2

Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia

NCT00462332

Leukemia

COMPLETED PHASE2

Combined Immunochemotherapy in Patients With T-Prolymphocytic Leukemia (T-PLL)

NCT01186640

T-cell-prolymphocytic Leukemia

COMPLETED PHASE2

Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

NCT02728050

Acute Biphenotypic Leukemia Acute Myeloid Leukemia de Novo Myelodysplastic Syndrome +2 more

COMPLETED PHASE1/PHASE2

Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

NCT02044796

Acute Biphenotypic Leukemia de Novo Myelodysplastic Syndrome Previously Treated Myelodysplastic Syndrome +3 more

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

T-Cell Large Granular Lymphocytic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MTX followed by fludarabine

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

Group Type EXPERIMENTAL

MTX followed by fludarabine

Intervention Type DRUG

MTX should be administered with 10-20mg weekly, calculated according to the body weight. Fludarabine should be administered with 25mg/m2 on day 1-3 of 28 days, up to 4 cycles

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MTX followed by fludarabine

MTX should be administered with 10-20mg weekly, calculated according to the body weight. Fludarabine should be administered with 25mg/m2 on day 1-3 of 28 days, up to 4 cycles

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

methotrexate, fludarabine phosphate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No