Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00274963
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : May 10, 2018
Information provided by:
German CLL Study Group

January 10, 2006
January 11, 2006
May 10, 2018
October 2004
November 2007   (Final data collection date for primary outcome measure)
Overall remission rate (partial and complete remission)
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Complete list of historical versions of study NCT00274963 on Archive Site
  • Time to progression
  • Safety and tolerability
  • Overall survival
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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)

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.



  • 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.

Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • Drug: bendamustine hydrochloride
  • Drug: mitoxantrone hydrochloride
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Köppler 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
October 2009
November 2007   (Final data collection date for primary outcome measure)


  • Cytologically and immunophenotypically confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)

    • Relapsed or refractory disease


  • No known hypersensitivity to any of the study medications
  • No uncontrolled infection
  • No impaired organ function


  • Not specified
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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German CLL Study Group
Not Provided
Study Chair: Hubert Koeppler, MD Praxis fuer Haematologie und Onkologie
German CLL Study Group
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP