Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT00274963
- Lead Sponsor
- German CLL Study Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall remission rate (partial and complete remission)
- Secondary Outcome Measures
Name Time Method Time to progression Safety and tolerability Overall survival
Trial Locations
- Locations (12)
Schwerpunktpraxis fuer Haematologie und Internistische Onkologie
🇩🇪Berlin, Germany
Internistische Gemeinschaftspraxis - Halle
🇩🇪Halle, Germany
Internistische Praxis - Neuss
🇩🇪Neuss, Germany
Deutsche Klinik fuer Diagnostik
🇩🇪Wiesbaden, Germany
Humaine - Clinic
🇩🇪Bad Saarow, Germany
Praxis fuer Haematologie und Onkologie
🇩🇪Koblenz, Germany
St. Marien Hospital
🇩🇪Hamm, Germany
Praxis Fuer Haematologie Internistische Onkologie
🇩🇪Koeln, Germany
Haematologische / Onkologische Schwerpunktpraxis
🇩🇪Krefeld, Germany
Internistische Onkologische Praxis - Kronach
🇩🇪Kronach, Germany
Haematologische Praxis
🇩🇪Weiden, Germany
Internistische Gemeinschaftspraxis - Oldenburg
🇩🇪Oldenburg, Germany