S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia
18 Years
N/A
Both
Leukemia
Trial Information
S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia
OBJECTIVES:
- To test whether the response rate (CR, CRi, or PR) in patients with purine
analog-refractory, B-cell chronic lymphocytic leukemia (CLL) after treatment with the
combination of bendamustine hydrochloride and rituximab is sufficiently high to warrant
further investigation.
- To evaluate the safety and tolerability of bendamustine hydrochloride and rituximab in
patients with B-cell CLL who are refractory to treatment with a purine-nucleoside
analog-containing regimen.
- To investigate, in a preliminary manner, the prognostic effects of pre-treatment
cytogenetic abnormalities identified by conventional cytogenetics and by FISH analyses
on response to treatment in this patient population.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on day 1 and bendamustine IV over 30 minutes on days 1-2.
Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. In course 1 only, patients also receive rituximab IV on day 2.
After completion of study treatment, patients are followed up periodically for 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically and immunophenotypically confirmed diagnosis of B-cell chronic
lymphocytic leukemia (CLL)
- Progressive or symptomatic disease
- Purine analog-refractory disease
- Must meet 1 of the following criteria:
- Intermediate- or high-risk modified-Rai stage
- Low-risk modified-Rai stage and progressive lymphocytosis, defined as > 50%
increase of absolute peripheral lymphocyte count over the lowest count during
the past 2 months
- Received 1 or more prior therapies for CLL
- Must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients"
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-3
- ANC > 1,000/mm³
- Platelet count > 50,000/mm³
- Serum creatinine ≤ 2 times upper limit of normal (ULN) OR creatinine clearance ≥ 50
mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No systemic fungal, bacterial, viral, or other infection that is not controlled
(i.e., exhibiting ongoing signs/symptoms related to the infection and without
improvement, despite appropriate antibiotics or other treatment)
- No other prior malignancy except for adequately treated basal cell or squamous cell
skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from
which the patient is currently in complete remission, or any other cancer from which
the patient has been disease free for 5 years
- HIV positivity allowed provided the following criteria are met:
- CD4 cells > 350/mm³
- No concurrent antiretroviral therapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 28 days since prior chemotherapy, any other investigational agents, or
major surgery
- More than 120 days since prior allogeneic or autologous hematopoietic stem cell
transplantation
- If prior allogeneic bone marrow transplantation, must meet the following
criteria:
- Performed > 120 days ago
- No acute graft-vs-host disease (GVHD) ≥ grade 2
- Receiving no immunosuppressive therapy for chronic GVHD
- No concurrent antiretroviral therapy for HIV-positive patients
- No concurrent CYP1A2 inhibitors
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate (CR, CRi, or PR)
Safety Issue:
No
Principal Investigator
Matt E. Kalaycio, MD
Investigator Role:
Study Chair
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000648192
NCT ID:
NCT00939328
Start Date:
September 2009
Completion Date:
September 2010
Related Keywords:
- Leukemia
- B-cell chronic lymphocytic leukemia
- refractory chronic lymphocytic leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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