Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)
3 other identifiers
interventional
60
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2004
Longer than P75 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 10, 2006
CompletedFirst Posted
Study publicly available on registry
January 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedMay 11, 2018
May 1, 2018
3.1 years
January 10, 2006
May 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall remission rate (partial and complete remission)
Secondary Outcomes (3)
Time to progression
Safety and tolerability
Overall survival
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (12)
Humaine - Clinic
Bad Saarow, 15526, Germany
Schwerpunktpraxis fuer Haematologie und Internistische Onkologie
Berlin, D-10117, Germany
Praxis Fuer Haematologie Internistische Onkologie
Cologne, D-50677, Germany
Internistische Gemeinschaftspraxis - Halle
Halle, 06110, Germany
St. Marien Hospital
Hamm, 59065, Germany
Praxis fuer Haematologie und Onkologie
Koblenz, D-56068, Germany
Haematologische / Onkologische Schwerpunktpraxis
Krefeld, 47798, Germany
Internistische Onkologische Praxis - Kronach
Kronach, 96317, Germany
Internistische Praxis - Neuss
Neuss, 41460, Germany
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, 26121, Germany
Haematologische Praxis
Weiden, D-92637, Germany
Deutsche Klinik fuer Diagnostik
Wiesbaden, D-65191, Germany
Related Publications (1)
Koppler H, Fuss H, Hurtz HJ, Knigge O, Losem C, Reschke D, Schmitz S, Weide R, Weiss J, Hallek M; GCLLSG. Bendamustine plus mitoxantrone for relapsed/refractory chronic lymphocytic leukaemia (CLL): results of a multicentre phase II study of the German CLL Study Group (GCLLSG). Br J Haematol. 2012 Jul;158(2):238-241. doi: 10.1111/j.1365-2141.2012.09132.x. Epub 2012 May 10.
PMID: 22571691RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hubert Koeppler, MD
Praxis fuer Haematologie und Onkologie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 10, 2006
First Posted
January 11, 2006
Study Start
October 1, 2004
Primary Completion
November 1, 2007
Study Completion
October 1, 2009
Last Updated
May 11, 2018
Record last verified: 2018-05