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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: November 5, 2013
Last verified: July 2007

January 10, 2006
November 5, 2013
October 2004
November 2007   (final data collection date for primary outcome measure)
Overall remission rate (partial and complete remission) [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00274963 on ClinicalTrials.gov Archive Site
  • Time to progression [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Leukemia
  • Drug: bendamustine hydrochloride
  • Drug: mitoxantrone hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Not Provided
November 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00274963
CDR0000455086, GCLLSG-CLL2K, EU-20551, RIBOSEPHARM-GCLLSK-CLL2K
Not Provided
Not Provided
German CLL Study Group
Not Provided
Study Chair: Hubert Koeppler, MD Praxis fuer Haematologie und Onkologie
National Cancer Institute (NCI)
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP