Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
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.
Drug: bendamustine hydrochloride
Drug: mitoxantrone hydrochloride
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)|
- Overall remission rate (partial and complete remission) [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Study Completion Date:||October 2009|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
- Determine the response rate (remission rate) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with bendamustine and mitoxantrone hydrochloride.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274963
|Humaine - Clinic|
|Bad Saarow, Germany, 15526|
|Schwerpunktpraxis fuer Haematologie und Internistische Onkologie|
|Berlin, Germany, D-10117|
|Internistische Gemeinschaftspraxis - Halle|
|Halle, Germany, 06110|
|St. Marien Hospital|
|Hamm, Germany, 59065|
|Praxis fuer Haematologie und Onkologie|
|Koblenz, Germany, D-56068|
|Praxis Fuer Haematologie Internistische Onkologie|
|Koeln, Germany, D-50677|
|Haematologische / Onkologische Schwerpunktpraxis|
|Krefeld, Germany, 47798|
|Internistische Onkologische Praxis - Kronach|
|Kronach, Germany, 96317|
|Internistische Praxis - Neuss|
|Neuss, Germany, 41460|
|Internistische Gemeinschaftspraxis - Oldenburg|
|Oldenburg, Germany, 26121|
|Weiden, Germany, D-92637|
|Deutsche Klinik fuer Diagnostik|
|Wiesbaden, Germany, D-65191|
|Study Chair:||Hubert Koeppler, MD||Praxis fuer Haematologie und Onkologie|