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
Recruitment status was Recruiting
Sponsor:
German CLL Study Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278265
First received: January 16, 2006
Last updated: May 9, 2009
Last verified: July 2007
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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 |
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: | May 9, 2009 |
| 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 May 23, 2013