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Phase I Clinical Trial of Bendamustine, Lenalidomide and Rituximab in B-Cell Lymphoid Malignancies

Phase 1
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma

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Trial Information

Phase I Clinical Trial of Bendamustine, Lenalidomide and Rituximab in B-Cell Lymphoid Malignancies

This is a Phase I, open-label, dose-escalation study of bendamustine and lenalidomide (BL)
and also bendamustine,lenalidomide, and rituximab (BLR) in relapsed/refractory CLL and
relapsed/refractory B-cell lymphomas. Phase I dose escalation will be done independently for
the CLL and NHL groups. In addition, the study will be conducted in 2 parts. In part I of
the study, the maximum tolerated dose of bendamustine and lenalidomide will be determined
independently for the CLL and NHL groups. In part II of the study, CLL and NHL subjects
will be enrolled at the MTD of BL determined in Part I for CLL and NHL and all subjects will
receive rituximab. Part II of the study will determine the MTD of BLT independently for the
NHL and CLL groups.

Inclusion Criteria:

- Documented relapsed or refractory B-cell NHL; CD-20 positive tumor. Indolent NHL:
follicular B-cell lymphoma, diffuse small lymphocytic lymphoma, lymphoplasmacytic
lymphoma, marginal zone lymphoma, transformed aggressive lymphomas, mantle cell
lymphoma and chronic lymphocytic leukemia

- Maximum of 6 prior chemotherapy regimens. Prior rituximab is allowed.

- Bidimensionally measurable disease

- ECOG performance status 0-2

- Absolute neutrophil count >/= 1000 and platelet count >/= 50,000

- Serum creatinine
- Adequate hepatic function

- Estimated life expectancy of at least 3 months

- All study participants must be registered into the mandatory RevAssist program and be
willing and able to comply with the requirements of RevAssist

- Able to take aspirin 81 mg daily as prophylactic anticoagulation

Exclusion Criteria:

- Chemotherapy or immunotherapy within 3 weeks prior to entering study or failure to
recover from adverse events due to any agents administered previously

- Use of investigational agents within 28 days of study

- Hematopoietic growth factors within 14 days of study

- History of prior high dose chemotherapy with allogeneic stem cell support

- History of prior radioimmunotherapy
- Concurrent treatment with therapeutic doses of systemic steroids

- Pregnant or lactating female subjects

- Concurrent, active malignancy other than lymphoma or CLL

- Primary CNS lymphoma

- Patients with a prior diagnosis of lymphoma active in the CNS are eligible only if
CNS has been treated, and they are neurologically stable with no progressive symptoms
off steroids and anti-convulsants

- Serious infection, medical condition, or psychiatric condition that, in the opinion
of the investigator, might interfere with the achievement of study objectives

- Hypersensitivity to murine proteins or to any component of rituximab

- Known positive for HIV or infectious hepatitis type C; hepatitis type B that is
active and uncontrolled

- Hypersensitivity to mannitol

- Evidence of laboratory tumor lysis syndrome by Cairo-Bishop criteria

- Subject with recent thromboembolic event (deep vein thrombosis or pulmonary embolism)
unless clinically stable and event occurred more than 2 weeks prior to enrollment.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Bruce D Cheson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

July 2014

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma
  • CLL
  • NHL
  • lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Georgetown University Hospital/Lombardi Cancer CenterWashington, District of Columbia  20007