This trial is active, not recruiting.

Condition leukemia
Treatments bendamustine hydrochloride, mitoxantrone hydrochloride
Phase phase 2
Sponsor German CLL Study Group
Start date October 2004
End date November 2007
Trial size 60 participants
Trial identifier NCT00274963, CDR0000455086, EU-20551, GCLLSG-CLL2K, RIBOSEPHARM-GCLLSK-CLL2K


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Primary purpose treatment

Primary Outcomes

Overall remission rate (partial and complete remission)
time frame:

Secondary Outcomes

Time to progression
time frame:
Safety and tolerability
time frame:
Overall survival
time frame:

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).