Clinical trial NCT00274963: Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Official title: Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: B-cell chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia
Lead sponsor: German CLL Study Group
Sponsor class: OTHER
First posted: 2006-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall remission rate (partial and complete remission)
Secondary outcomes:
measure: Time to progression
measure: Safety and tolerability
measure: Overall survival
Other outcomes:
Locations:
city: Bad Saarow
country: Germany
facility: Humaine - Clinic
city: Berlin
country: Germany
facility: Schwerpunktpraxis fuer Haematologie und Internistische Onkologie
city: Halle
country: Germany
facility: Internistische Gemeinschaftspraxis - Halle
city: Hamm
country: Germany
facility: St. Marien Hospital
city: Koblenz
country: Germany
facility: Praxis fuer Haematologie und Onkologie
city: Koeln
country: Germany
facility: Praxis Fuer Haematologie Internistische Onkologie
city: Krefeld
country: Germany
facility: Haematologische / Onkologische Schwerpunktpraxis
city: Kronach
country: Germany
facility: Internistische Onkologische Praxis - Kronach
city: Neuss
country: Germany
facility: Internistische Praxis - Neuss
city: Oldenburg
country: Germany
facility: Internistische Gemeinschaftspraxis - Oldenburg
city: Weiden
country: Germany
facility: Haematologische Praxis
city: Wiesbaden
country: Germany
facility: Deutsche Klinik fuer Diagnostik
Study officials:
affiliation: Praxis fuer Haematologie und Onkologie
name: Hubert Koeppler, MD
role: STUDY_CHAIR
References:
citation: 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.