Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
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| ClinicalTrials.gov Identifier: NCT00274963 |
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Recruitment Status :
Completed
First Posted : January 11, 2006
Last Update Posted : May 11, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Lymphocytic Leukemia | Drug: bendamustine hydrochloride Drug: mitoxantrone hydrochloride | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Non-Randomized |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM) |
| Study Start Date : | October 2004 |
| Actual Primary Completion Date : | November 2007 |
| Actual Study Completion Date : | October 2009 |
- Overall remission rate (partial and complete remission)
- Time to progression
- Safety and tolerability
- Overall survival
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274963
| Germany | |
| 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 | |
| Haematologische Praxis | |
| Weiden, Germany, D-92637 | |
| Deutsche Klinik fuer Diagnostik | |
| Wiesbaden, Germany, D-65191 | |
| Study Chair: | Hubert Koeppler, MD | Praxis fuer Haematologie und Onkologie |
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00274963 |
| Other Study ID Numbers: |
CLL2K EU-20551 RIBOSEPHARM-GCLLSK-CLL2K |
| First Posted: | January 11, 2006 Key Record Dates |
| Last Update Posted: | May 11, 2018 |
| Last Verified: | May 2018 |
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B-cell chronic lymphocytic leukemia refractory chronic lymphocytic leukemia |
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Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Bendamustine Hydrochloride Mitoxantrone |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |