- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00278265
Methotrexate Followed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia
First Line Therapy With Methotrexate (MTX) and Second Line Therapy With Fludarabine of Patients With T-Cell Large Granular Lymphocyte Leukemia (T-LGL)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Berlin, Germany, D-13125
- Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
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Kiel, Germany, D-24105
- University Hospital Schleswig-Holstein - Kiel Campus
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Munich, Germany, D-80337
- I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
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Mutlangen, Germany, D-73557
- Klinikum Schwaebisch Gmuend Stauferklinik
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Norderstedt, Germany, 22844
- Praxis fuer Haematologie und Interne Onkologie
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Siegen, Germany, D-57072
- St. Marien - Krankenhaus Siegen GMBH
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Ulm, Germany, D-89081
- Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: 12 months after inclusion in the study
|
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
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12 months after inclusion in the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of remission
Time Frame: up to 24 months after inclusion in the study
|
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
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up to 24 months after inclusion in the study
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Molecular remission rate
Time Frame: 2 months after the last dose of study medication
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2 months after the last dose of study medication
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Adverse events rate and severity
Time Frame: up to 28 days after the last dose of study medication
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Adverse events were reported according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC version 2.0)
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up to 28 days after the last dose of study medication
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Michael Kneba, University Hospital Schleswig-Holstein
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, T-Cell
- Leukemia
- Leukemia, Lymphoid
- Leukemia, Large Granular Lymphocytic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Fludarabine
- Fludarabine phosphate
- Methotrexate
Other Study ID Numbers
- LGL1
- GCLLSG-LGL1
- EU-20564
- CDR0000454596 (Other Identifier: Clinical Data Repository)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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