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

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ClinicalTrials.gov Identifier: NCT00274963
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : May 10, 2018
Sponsor:
Information provided by:
German CLL Study Group

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 Type : Interventional  (Clinical Trial)
Estimated 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 : October 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : October 2009





Primary Outcome Measures :
  1. Overall remission rate (partial and complete remission)

Secondary Outcome Measures :
  1. Time to progression
  2. Safety and tolerability
  3. Overall survival


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274963


Locations
Germany
Humaine - Clinic
Bad Saarow, Germany, 15526
Schwerpunktpraxis fuer Haematologie und Internistische Onkologie
Berlin, Germany, D-10117
Internistische Gemeinschaftspraxis - Halle
Halle, Germany, 06110
St. Marien Hospital
Hamm, Germany, 59065
Praxis fuer Haematologie und Onkologie
Koblenz, Germany, D-56068
Praxis Fuer Haematologie Internistische Onkologie
Koeln, Germany, D-50677
Haematologische / Onkologische Schwerpunktpraxis
Krefeld, Germany, 47798
Internistische Onkologische Praxis - Kronach
Kronach, Germany, 96317
Internistische Praxis - Neuss
Neuss, Germany, 41460
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, Germany, 26121
Haematologische Praxis
Weiden, Germany, D-92637
Deutsche Klinik fuer Diagnostik
Wiesbaden, Germany, D-65191
Sponsors and Collaborators
German CLL Study Group
Investigators
Study Chair: Hubert Koeppler, MD Praxis fuer Haematologie und Onkologie

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00274963     History of Changes
Other Study ID Numbers: CLL2K
EU-20551
RIBOSEPHARM-GCLLSK-CLL2K
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by German CLL Study Group:
B-cell chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Bendamustine Hydrochloride
Mitoxantrone
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors