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NCT Number: NCT00274963

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Humaine - Clinic, Bad Saarow, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bendamustine Hydrochloride

Drug

mitoxantrone hydrochloride

Drug

Primary outcomes

  1. Overall remission rate (partial and complete remission)

Secondary outcomes

  1. Time to progression

  2. Safety and tolerability

  3. Overall survival

Sponsors and collaborators

Lead sponsor

German CLL Study Group

Other

Registry information

Official study title

Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Jan 11, 2006
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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