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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274963
• Other study ID #: CLL2K
• Secondary ID: EU-20551RIBOSEPH
• Status: Completed
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: October 2009

Study information

• Verified date: May 2018
• Source: German CLL Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• bendamustine hydrochloride

• mitoxantrone hydrochloride

Locations

Country	Name	City	State
Germany	Humaine - Clinic	Bad Saarow
Germany	Schwerpunktpraxis fuer Haematologie und Internistische Onkologie	Berlin
Germany	Internistische Gemeinschaftspraxis - Halle	Halle
Germany	St. Marien Hospital	Hamm
Germany	Praxis fuer Haematologie und Onkologie	Koblenz
Germany	Praxis Fuer Haematologie Internistische Onkologie	Koeln
Germany	Haematologische / Onkologische Schwerpunktpraxis	Krefeld
Germany	Internistische Onkologische Praxis - Kronach	Kronach
Germany	Internistische Praxis - Neuss	Neuss
Germany	Internistische Gemeinschaftspraxis - Oldenburg	Oldenburg
Germany	Haematologische Praxis	Weiden
Germany	Deutsche Klinik fuer Diagnostik	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
German CLL Study Group

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall remission rate (partial and complete remission)
Secondary	Time to progression
Secondary	Safety and tolerability
Secondary	Overall survival

External Links

•   Click here for more information about this study: CLL2K (German CLL Study Group)