Clinical trial NCT00278265: Methotrexate Followed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia
Official title: First Line Therapy With Methotrexate (MTX) and Second Line Therapy With Fludarabine of Patients With T-Cell Large Granular Lymphocyte Leukemia (T-LGL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: T-Cell Large Granular Lymphocytic Leukemia
Keywords: T-cell large granular lymphocyte leukemia
anemia
neutropenia
Lead sponsor: German CLL Study Group
Sponsor class: OTHER
First posted: 2006-01-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Response rate
timeFrame: 12 months after inclusion in the study
Secondary outcomes:
measure: Duration of remission
timeFrame: up to 24 months after inclusion in the study
measure: Molecular remission rate
timeFrame: 2 months after the last dose of study medication
measure: Adverse events rate and severity
timeFrame: up to 28 days after the last dose of study medication
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein - Kiel Campus
city: Munich
country: Germany
facility: I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
city: Mutlangen
country: Germany
facility: Klinikum Schwaebisch Gmuend Stauferklinik
city: Norderstedt
country: Germany
facility: Praxis fuer Haematologie und Interne Onkologie
city: Siegen
country: Germany
facility: St. Marien - Krankenhaus Siegen GMBH
city: Ulm
country: Germany
facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Michael Kneba
role: STUDY_CHAIR
References: