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

T-Cell Large Granular Lymphocytic Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00278265
• Other study ID #: LGL1
• Secondary ID: GCLLSG-LGL1EU-20
• Status: Terminated
• Phase: Phase 2
• First received: January 16, 2006
• Last updated: September 30, 2016
• Start date: June 2005
• Est. completion date: December 2009

Study information

• Verified date: September 2016
• Source: German CLL Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• T-Cell Large Granular Lymphocytic Leukemia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	Robert Roessle Comprehensive Cancer Center - Charite Campus Buch	Berlin
Germany	University Hospital Schleswig-Holstein - Kiel Campus	Kiel
Germany	I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen	Munich
Germany	Klinikum Schwaebisch Gmuend Stauferklinik	Mutlangen
Germany	Praxis fuer Haematologie und Interne Onkologie	Norderstedt
Germany	St. Marien - Krankenhaus Siegen GMBH	Siegen
Germany	Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
German CLL Study Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	he remission status was assessed according to the guidelines of the National Cancer Institute Sponsored Working Group (NCI-WG) [20 Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996; 87: 4990-4997.]. Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission	12 months after inclusion in the study	No
Secondary	Duration of remission	he remission status was assessed according to the guidelines of the National Cancer Institute Sponsored Working Group (NCI-WG) [20 Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996; 87: 4990-4997.]. Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission	up to 24 months after inclusion in the study	No
Secondary	Molecular remission rate		2 months after the last dose of study medication	No
Secondary	Adverse events rate and severity	Adverse events were reported according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC version 2.0)	up to 28 days after the last dose of study medication	Yes

External Links

•   Click here for more information about this study: LGL1 (German CLL Study Group)