Methotrexate Folowed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia (CDR0000454596)

This study has been terminated.
(slow recruitment)
Sponsor:
Information provided by (Responsible Party):
German CLL Study Group
ClinicalTrials.gov Identifier:
NCT00278265
First received: January 16, 2006
Last updated: August 10, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention Phase
Anemia
Leukemia
Neutropenia
Drug: MTX followed by fludarabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by German CLL Study Group:

Primary Outcome Measures:
  • Response rate [ Time Frame: 12 months after inclusion in the study ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Duration of remission [ Time Frame: up to 24 months after inclusion in the study ] [ Designated as safety issue: No ]
    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

  • Molecular remission rate [ Time Frame: 2 months after the last dose of study medication ] [ Designated as safety issue: No ]
  • Adverse events rate and severity [ Time Frame: up to 28 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
    Adverse events were reported according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC version 2.0)


Enrollment: 12
Study Start Date: June 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: MTX followed by fludarabine
MTX should be administered with 10-20mg weekly, calculated according to the body weight. Fludarabine should be administerred with 25mg/m2 on day 1-3 of 28 days, up to 4 cycles
Other Name: methotrexate, fludarabine phosphate

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

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278265

Locations
Germany
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Berlin, Germany, D-13125
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24105
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
Munich, Germany, D-80337
Klinikum Schwaebisch Gmuend Stauferklinik
Mutlangen, Germany, D-73557
Praxis fuer Haematologie und Interne Onkologie
Norderstedt, Germany, 22844
St. Marien - Krankenhaus Siegen GMBH
Siegen, Germany, D-57072
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, Germany, D-89081
Sponsors and Collaborators
German CLL Study Group
Investigators
Study Chair: Michael Kneba University of Schleswig-Holstein
  More Information

Responsible Party: German CLL Study Group
ClinicalTrials.gov Identifier: NCT00278265     History of Changes
Other Study ID Numbers: LGL1  GCLLSG-LGL1  EU-20564 
Study First Received: January 16, 2006
Last Updated: August 10, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by German CLL Study Group:
T-cell large granular lymphocyte leukemia
anemia
neutropenia

Additional relevant MeSH terms:
Leukemia
Neutropenia
Leukemia, Large Granular Lymphocytic
Neoplasms by Histologic Type
Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Leukemia, T-Cell
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methotrexate
Fludarabine phosphate
Vidarabine
Fludarabine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 25, 2016