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Combination Chemotherapy With or Without G-CSF in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

This study has been terminated.
(low recruitment)
Sponsor:
Information provided by (Responsible Party):
German CLL Study Group
ClinicalTrials.gov Identifier:
NCT00416910
First received: December 27, 2006
Last updated: September 23, 2016
Last verified: September 2016

December 27, 2006
September 23, 2016
July 1999
September 2003   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00416910 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy With or Without G-CSF in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Treatment of Advanced Chronic Lymphocytic Leukemia (CLL) Fludarabine, Mitoxantrone and Cyclophosphamide With or Without G-CSF

RATIONALE: Drugs used in chemotherapy, such as fludarabine, mitoxantrone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Colony stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of combination chemotherapy. It is not yet known whether giving combination chemotherapy alone is more effective than combination chemotherapy together with G-CSF in treating patients with chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy together with G-CSF to see how well it works compared to giving combination chemotherapy alone in treating patients with relapsed stage I, stage II, stage III, or stage IV chronic lymphocytic leukemia.

OBJECTIVES:

Primary

  • Compare the rate of remission, severe infections, and side effects in patients with relapsed advanced chronic lymphocytic leukemia treated with fludarabine, mitoxantrone hydrochloride, and cyclophosphamide with vs without filgrastim.

Secondary

  • Compare the overall survival, progression-free survival, and quality of remission in these patients.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive fludarabine IV on days 1-3, mitoxantrone hydrochloride IV on day 1, and cyclophosphamide IV on days 1-3.
  • Arm II: Patients receive fludarabine, mitoxantrone hydrochloride, and cyclophosphamide as in arm I and filgrastim (G-CSF) beginning on day 6 and continuing until blood counts recover.

In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • Biological: Filgrastim
    Other Name: Neupogen
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
  • Drug: Mitoxantrone
  • Active Comparator: FCM
    Fludarabine i.v. (25 mg/m2/d, d1-3) Cyclophosphamide i.v. (200 mg/m2/d, d1-3) Mitoxantrone i.v. (8 mg/m2, d1) q28d, max. 6 cycles
    Interventions:
    • Drug: Fludarabine
    • Drug: Cyclophosphamide
    • Drug: Mitoxantrone
  • Experimental: FCM + G-CSF
    Fludarabine i.v. (25 mg/m2/d, d1-3) Cyclophosphamide i.v. (200 mg/m2/d, d1-3) Mitoxantrone i.v. (8 mg/m2, d1) Filgrastim (G-CSF) s.c. (5 µg/kg/d beginning on day +6 until neutrophil recovery above 1500/µl.) q28d, max. 6 cycles
    Interventions:
    • Biological: Filgrastim
    • Drug: Fludarabine
    • Drug: Cyclophosphamide
    • Drug: Mitoxantrone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
83
September 2007
September 2003   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Confirmed relapsed and advanced chronic lymphocytic leukemia (CLL)

    • Binet stage B or C disease with rapid disease progression, enlarged lymph nodes and organs, or severe B-symptoms
  • No prior non-response to fludarabine combination therapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Life expectancy > 6 months
  • No severe organ dysfunction
  • No other prior or concurrent neoplasm, autoimmune hemolytic anemia, or thrombocytopenia

PRIOR CONCURRENT THERAPY:

  • No more than three previous treatment regimens for CLL (fludarabine allowed)
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00416910
GCLLSG-CLL6, CDR0000455571, EU-20558, AMGEN-GCLLSG-CLL6, MEDAC-GCLLSG-CLL6
No
No
Not Provided
German CLL Study Group
German CLL Study Group
Not Provided
Principal Investigator: Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne
German CLL Study Group
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP