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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia

Intervention: bendamustine hydrochloride (Drug); mitoxantrone hydrochloride (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: German CLL Study Group

Official(s) and/or principal investigator(s):
Hubert Koeppler, MD, Study Chair, Affiliation: Praxis fuer Haematologie und Onkologie


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.

Clinical Details

Official title: Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)

Study design: Allocation: Non-Randomized, Primary Purpose: Treatment

Primary outcome: Overall remission rate (partial and complete remission)

Secondary outcome:

Time to progression

Safety and tolerability

Overall survival

Detailed 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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.



- 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

Locations and Contacts

Humaine - Clinic, Bad Saarow 15526, Germany

Schwerpunktpraxis fuer Haematologie und Internistische Onkologie, Berlin D-10117, Germany

Internistische Gemeinschaftspraxis - Halle, Halle 06110, Germany

St. Marien Hospital, Hamm 59065, Germany

Praxis fuer Haematologie und Onkologie, Koblenz D-56068, Germany

Praxis Fuer Haematologie Internistische Onkologie, Koeln D-50677, 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

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2004
Last updated: November 5, 2013

Page last updated: August 23, 2015

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