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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274963
First received: January 10, 2006
Last updated: January 21, 2009
Last verified: July 2007
History of Changes
  Purpose

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 Intervention Phase
Leukemia
 Drug: bendamustine hydrochloride
Drug: mitoxantrone hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall remission rate (partial and complete remission) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2004
Estimated Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00274963     History of Changes
Other Study ID Numbers: CDR0000455086, GCLLSG-CLL2K, EU-20551, RIBOSEPHARM-GCLLSK-CLL2K
Study First Received: January 10, 2006
Last Updated: January 21, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
B-cell chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Mitoxantrone
 Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013