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

NCT ID: NCT00416910

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-07-31
• Study Completion Date: 2007-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Fludarabine

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Mitoxantrone

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

Filgrastim

Intervention Type: BIOLOGICAL

Fludarabine

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Mitoxantrone

Intervention Type: DRUG

Interventions

Filgrastim

Intervention Type: BIOLOGICAL

Fludarabine

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Mitoxantrone

Intervention Type: DRUG

Other Intervention Names

Neupogen

Eligibility Criteria

Inclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German CLL Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Hallek, MD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Universitaetsklinik I at the University of Cologne

Related Links

http://www.dcllsg.de

German CLL Study Group

Other Identifiers

CDR0000455571

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20558

Identifier Type: -

Identifier Source: secondary_id

AMGEN-GCLLSG-CLL6

Identifier Type: -

Identifier Source: secondary_id

MEDAC-GCLLSG-CLL6

Identifier Type: -

Identifier Source: secondary_id

GCLLSG-CLL6

Identifier Type: -

Identifier Source: org_study_id