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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Safety Issue:

No

Principal Investigator

Clemens M. Wendtner

Investigator Role:

Study Chair

Investigator Affiliation:

Medizinische Universitaetsklinik I at the University of Cologne

Authority:

Unspecified

Study ID:

CDR0000455087

NCT ID:

NCT00274989

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Leukemia
  • B-cell chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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