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Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, B Chronic Lymphocytic Leukemia

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Trial Information

Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study


Subjects will receive lenalidomide, bendamustine and rituximab in cycles of 28 days (4
weeks). Lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on
days 1-21 of all subsequent cycles. Bendamustine will be administered through a vein (IV
infusion) on days 1 and 2 of each cycle. Rituximab will be administered as an IV infusion on
day 1 of each cycle.

Subjects will receive routine blood tests and physical exam during each cycle. Tumor
assessments by CT scan will be performed during cycles 2, 4, and 6.


Inclusion Criteria:



- Diagnosed with B-cell CLL or SLL (chronic lymphocytic leukemia or small lymphocytic
leukemia)

- Life expectancy > 3 months

- Organ and marrow function with protocol parameters

- Able to take aspirin daily

Exclusion Criteria:

- Prior systemic therapy for CLL/SLL including chemotherapy or antibody therapy

- Pregnant or breast-feeding

- Serious medical condition, laboratory abnormality, or psychiatric illness that would
prevent the subject from signing informed consent

- Known hypersensitivity to thalidomide or lenalidomide

- Prior use of lenalidomide

- Concurrent use of other anti-cancer agents or treatments

- HIV positive

- Prior history of another malignancy unless disease free for at least 2 years

- Uncontrolled intercurrent illness

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Jeremy Abramson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

11-016

NCT ID:

NCT01400685

Start Date:

December 2012

Completion Date:

November 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • B Chronic Lymphocytic Leukemia
  • CLL
  • Leukemia
  • Untreated
  • B-CLL
  • SLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617