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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

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


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.

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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Michael Hallek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medizinische Universitaetsklinik I at the University of Cologne

Authority:

United States: Federal Government

Study ID:

CDR0000455571

NCT ID:

NCT00416910

Start Date:

Completion Date:

Related Keywords:

  • Leukemia
  • refractory chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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