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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Treatment of Advanced Chronic Lymphocytic Leukemia (CLL) Fludarabine, Mitoxantrone and Cyclophosphamide With or Without G-CSF

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00416910
• Other study ID #: GCLLSG-CLL6
• Secondary ID: CDR0000455571EU-
• Status: Terminated
• Phase: Phase 3
• First received: December 27, 2006
• Last updated: September 23, 2016
• Start date: July 1999
• Est. completion date: September 2007

Study information

• Verified date: September 2016
• Source: German CLL Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: September 2007
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Biological:
• Filgrastim

Drug:
• Fludarabine

• Cyclophosphamide

• Mitoxantrone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
German CLL Study Group

External Links

•   German CLL Study Group