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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: bendamustine hydrochloride
* Drug: mitoxantrone hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bendamustine hydrochloride|nan|
|Drug: mitoxantrone hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall remission rate (partial and complete remission) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Safety and tolerability |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia