Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00274963

Enrollment

Registered

2006-01-11

Start date

2004-10-31

Completion date

2009-10-31

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia

Brief summary

RATIONALE: Drugs used in chemotherapy, such as bendamustine and mitoxantrone, 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. PURPOSE: This phase II trial is studying how well giving bendamustine together with mitoxantrone works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.

Detailed description

OBJECTIVES: Primary * Determine the response rate (remission rate) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with bendamustine and mitoxantrone hydrochloride. Secondary * Determine the progression-free survival and overall survival of patients treated with this regimen. * Determine the safety and tolerability of this regimen in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive bendamustine IV over 1 hour on days1-3 and mitoxantrone hydrochloride IV over 30 minutes on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease (i.e., complete response or partial response) after 2 courses receive 2 additional courses of treatment for a total of 4 courses. After completion of study treatment, patients are followed periodically for survival. PROJECTED ACCRUAL: A total 60 patients will be accrued for this study.

Interventions

DRUGbendamustine hydrochloride

DRUGmitoxantrone hydrochloride

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Cytologically and immunophenotypically confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) * Relapsed or refractory disease PATIENT CHARACTERISTICS: * No known hypersensitivity to any of the study medications * No uncontrolled infection * No impaired organ function PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

Measure	Time frame
Overall remission rate (partial and complete remission)	—

Secondary

Measure	Time frame
Time to progression	—
Safety and tolerability	—
Overall survival	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026