Methotrexate as First-Line Therapy and Fludarabine as Second-Line Therapy in Treating Patients With T-Cell Large Granular Lymphocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: January 16, 2006
Last updated: August 23, 2013
Last verified: July 2007

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
Drug: fludarabine phosphate
Drug: methotrexate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of remission [ Designated as safety issue: No ]
  • Molecular remission rate [ Designated as safety issue: No ]
  • Adverse events rate and severity [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2005
Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Confirmed diagnosis of T-cell large granular lymphocytic (T-LGL) leukemia
  • Must have concurrent anemia or neutropenia


  • Life expectancy ≥ 2 years
  • Not pregnant
  • Fertile patients must use effective contraception
  • No other malignancy
  • No active infection


  • No prior immunosuppressive treatment
  • No previous treatment with methotrexate or fludarabine
  Contacts and Locations
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Please refer to this study by its identifier: NCT00278265

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch Recruiting
Berlin, Germany, D-13125
Contact: Contact Person    49-30-9417-1243   
University Hospital Schleswig-Holstein - Kiel Campus Recruiting
Kiel, Germany, D-24105
Contact: Contact Person    49-431-1697-5231   
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen Recruiting
Munich, Germany, D-80337
Contact: Contact Person    49-89-7095-4230    manuela.bergmann@med.uni-muenchen.deu   
Klinikum Schwaebisch Gmuend Stauferklinik Recruiting
Mutlangen, Germany, D-73557
Contact: Contact Person    49-717-1701-1302   
Praxis fuer Haematologie und Interne Onkologie Recruiting
Norderstedt, Germany, 22844
Contact: Contact Person    49-40-526-5060   
St. Marien - Krankenhaus Siegen GMBH Recruiting
Siegen, Germany, D-57072
Contact: Contact Person    49-271-231-1310   
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm Recruiting
Ulm, Germany, D-89081
Contact: Contact Person    49-731-5004-5548   
Sponsors and Collaborators
German CLL Study Group
Study Chair: Michael Kneba University of Schleswig-Holstein
  More Information Identifier: NCT00278265     History of Changes
Other Study ID Numbers: CDR0000454596  GCLLSG-LGL1  EU-20564 
Study First Received: January 16, 2006
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
T-cell large granular lymphocyte leukemia

Additional relevant MeSH terms:
Leukemia, Large Granular Lymphocytic
Neoplasms by Histologic Type
Leukocyte Disorders
Hematologic Diseases
Leukemia, T-Cell
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists processed this record on July 25, 2016