Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
This trial is active, not recruiting.
|Treatments||bendamustine hydrochloride, mitoxantrone hydrochloride|
|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|
|Bad Saarow, Germany||Humaine - Clinic||no longer recruiting|
|Berlin, Germany||Schwerpunktpraxis fuer Haematologie und Internistische Onkologie||no longer recruiting|
|Halle, Germany||Internistische Gemeinschaftspraxis - Halle||no longer recruiting|
|Hamm, Germany||St. Marien Hospital||no longer recruiting|
|Koblenz, Germany||Praxis fuer Haematologie und Onkologie||no longer recruiting|
|Koeln, Germany||Praxis Fuer Haematologie Internistische Onkologie||no longer recruiting|
|Krefeld, Germany||Haematologische / Onkologische Schwerpunktpraxis||no longer recruiting|
|Kronach, Germany||Internistische Onkologische Praxis - Kronach||no longer recruiting|
|Neuss, Germany||Internistische Praxis - Neuss||no longer recruiting|
|Oldenburg, Germany||Internistische Gemeinschaftspraxis - Oldenburg||no longer recruiting|
|Weiden, Germany||Haematologische Praxis||no longer recruiting|
|Wiesbaden, Germany||Deutsche Klinik fuer Diagnostik||no longer recruiting|
Overall remission rate (partial and complete remission)
Time to progression
Safety and tolerability
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
|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.|
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