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S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia

Phase 2
18 Years
Not Enrolling

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Trial Information

S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia


- 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


- 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"


- 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

- 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


- 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

- If prior allogeneic bone marrow transplantation, must meet the following

- 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:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (CR, CRi, or PR)

Safety Issue:


Principal Investigator

Matt E. Kalaycio, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Food and Drug Administration

Study ID:




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