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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278265
First received: January 16, 2006
Last updated: August 23, 2013
Last verified: July 2007
  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: 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:

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

Locations
Germany
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch Recruiting
Berlin, Germany, D-13125
Contact: Contact Person    49-30-9417-1243    klima@rrk.charite-buch.de   
University Hospital Schleswig-Holstein - Kiel Campus Recruiting
Kiel, Germany, D-24105
Contact: Contact Person    49-431-1697-5231    m.ritgen@med2.uni-kiel.de   
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    holger.hebart@klinikum-sgd.de   
Praxis fuer Haematologie und Interne Onkologie Recruiting
Norderstedt, Germany, 22844
Contact: Contact Person    49-40-526-5060    dr.r.hoffmann.nordersedt@t-online.de   
St. Marien - Krankenhaus Siegen GMBH Recruiting
Siegen, Germany, D-57072
Contact: Contact Person    49-271-231-1310    tobias.gaska@marienkrankenhaus.com   
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm Recruiting
Ulm, Germany, D-89081
Contact: Contact Person    49-731-5004-5548    stephan.stigenbauer@uniklinik-ulm.de   
Sponsors and Collaborators
German CLL Study Group
Investigators
Study Chair: Michael Kneba University of Schleswig-Holstein
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov 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
anemia
neutropenia

Additional relevant MeSH terms:
Anemia
Leukemia
Leukemia, Lymphoid
Neutropenia
Leukemia, Large Granular Lymphocytic
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Leukemia, T-Cell
Methotrexate
Fludarabine monophosphate
Vidarabine
Fludarabine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 21, 2014