Bendamustine and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274989
First received: January 10, 2006
Last updated: August 23, 2013
Last verified: July 2007
  Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with bendamustine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bendamustine together with rituximab works in treating patients with relapsed B-cell chronic lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Biological: rituximab
Drug: bendamustine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Phase II Trial of Bendamustine in Combination With Rituximab for Patients With Relapsed Chronic Lymphocytic Leukemia. CLL2M Protocol of the German CLL-Study Group (GCLLSG)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]

Estimated Enrollment: 61
Study Start Date: November 2005
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the overall response rate in patients with relapsed B-cell chronic lymphocytic leukemia treated with bendamustine and rituximab.

Secondary

  • Determine the overall response rate in biologically defined risk groups treated with this regimen.
  • Determine the duration of response, minimal residual disease response rate, and complete response rate in patients treated with this regimen.
  • Determine the event-free survival of patients treated with this regimen.
  • Determine the safety and toxicity of this regimen in these patients.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive rituximab on day 0 in course 1 and on day 1 in courses 2-6. Patients also receive bendamustine on days 1 and 2 in courses 1-6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 156 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) requiring treatment

    • Previously untreated Binet stage C or Binet B requiring treatment according to NCI criteria
    • Relapsed or refractory disease after treatment with ≥ 1 but no more than 3 prior regimens

      • Prior bendamustine allowed provided patient achieved at least a partial response that lasted at least 6 months AND completed treatment more than 6 months ago
  • No progression to more aggressive B-cell cancers, such as Richter's syndrome
  • No known CNS involvement with B-CLL

PATIENT CHARACTERISTICS:

  • WHO 0-2
  • Life expectancy > 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm^3, unless due to bone marrow involvement of CLL
  • Platelet count ≥ 75,000/mm^3, unless due to bone marrow involvement of CLL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN) OR
  • Creatinine clearance > 30 mL/min
  • Bilirubin, AST, and ALT ≤ 2 times ULN, unless directly attributable to the patient's tumor
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for a minimum of 6 months after study therapy
  • No history of anaphylaxis after exposure to monoclonal antibodies
  • No known HIV
  • No hepatitis B or C positivity
  • No major organ malfunction (liver, kidney) that could interfere with the patient's ability to participate in the study
  • No active infection or history of severe infection (grade 4) within 3 months prior to study registration
  • No medical condition requiring prolonged use of oral corticosteroids (> 1 month)
  • No severe diabetes
  • No active secondary malignancy
  • No pulmonary disease (chronic obstructive pulmonary disease [COPD] with hypoxemia)
  • No tuberculosis
  • No New York Heart Association class III or IV heart disease
  • No severe hypertension
  • No other severe concurrent diseases
  • No mental disorders
  • No circumstance at the time of study entry that would preclude completion of the study or the required follow-up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 3 weeks since prior anticancer therapy, major surgery, or irradiation
  • Recovered from the acute side effects incurred as a result of previous therapy
  • No use of investigational agents within 30 days prior to study
  • No participation in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274989

  Show 58 Study Locations
Sponsors and Collaborators
German CLL Study Group
Investigators
Study Chair: Clemens M. Wendtner Medizinische Universitaetsklinik I at the University of Cologne
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00274989     History of Changes
Other Study ID Numbers: CDR0000455087, GCLLSG-CLL2M, EU-20552, EUDRACT-2005-001596-34, ROCHE-GCLLSG-CLL2M
Study First Received: January 10, 2006
Last Updated: August 23, 2013
Health Authority: Unspecified

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
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bendamustine
Nitrogen Mustard Compounds
Rituximab
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014