NCT00278265

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2005

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

4.5 years

First QC Date

January 16, 2006

Last Update Submit

September 30, 2016

Conditions

T-Cell Large Granular Lymphocytic Leukemia

Keywords

T-cell large granular lymphocyte leukemiaanemianeutropenia

Outcome Measures

Primary Outcomes (1)

  • Response rate

    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

    12 months after inclusion in the study

Secondary Outcomes (3)

  • Duration of remission

    up to 24 months after inclusion in the study

  • Molecular remission rate

    2 months after the last dose of study medication

  • Adverse events rate and severity

    up to 28 days after the last dose of study medication

Study Arms (1)

MTX followed by fludarabine

EXPERIMENTAL

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

Interventions

MTX followed by fludarabineDRUG

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

Also known as: methotrexate, fludarabine phosphate
MTX followed by fludarabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

Berlin, D-13125, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

Munich, D-80337, Germany

Location

Klinikum Schwaebisch Gmuend Stauferklinik

Mutlangen, D-73557, Germany

Location

Praxis fuer Haematologie und Interne Onkologie

Norderstedt, 22844, Germany

Location

St. Marien - Krankenhaus Siegen GMBH

Siegen, D-57072, Germany

Location

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, D-89081, Germany

Location

MeSH Terms

Conditions

Leukemia, Large Granular LymphocyticAnemiaNeutropenia

Interventions

Methotrexatefludarabine phosphate

Condition Hierarchy (Ancestors)

Leukemia, T-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte Disorders

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Michael Kneba

    University Hospital Schleswig-Holstein

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 18, 2006

Study Start

June 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 3, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(7)