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

Sponsor

German CLL Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00274963

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: bendamustine hydrochloride Drug: mitoxantrone hydrochloride	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2004

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Oct 1, 2009

Outcome Measures

Primary Outcome Measures

Overall remission rate (partial and complete remission) []

Secondary Outcome Measures

Time to progression []
Safety and tolerability []
Overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Humaine - Clinic	Bad Saarow	Germany	15526
2	Schwerpunktpraxis fuer Haematologie und Internistische Onkologie	Berlin	Germany	D-10117
3	Internistische Gemeinschaftspraxis - Halle	Halle	Germany	06110
4	St. Marien Hospital	Hamm	Germany	59065
5	Praxis fuer Haematologie und Onkologie	Koblenz	Germany	D-56068
6	Praxis Fuer Haematologie Internistische Onkologie	Koeln	Germany	D-50677
7	Haematologische / Onkologische Schwerpunktpraxis	Krefeld	Germany	47798
8	Internistische Onkologische Praxis - Kronach	Kronach	Germany	96317
9	Internistische Praxis - Neuss	Neuss	Germany	41460
10	Internistische Gemeinschaftspraxis - Oldenburg	Oldenburg	Germany	26121
11	Haematologische Praxis	Weiden	Germany	D-92637
12	Deutsche Klinik fuer Diagnostik	Wiesbaden	Germany	D-65191