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A Phase I Dose Escalation Study of Lenalidomide (Revlimid) in Combination With Fludarabine-Rituximab (Rituxan) for Previously Untreated CLL/SLL

Phase 1
18 Years
Not Enrolling
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia

Thank you

Trial Information

A Phase I Dose Escalation Study of Lenalidomide (Revlimid) in Combination With Fludarabine-Rituximab (Rituxan) for Previously Untreated CLL/SLL

- Participants will be treated in groups (cohorts) of three to six subjects per cohort.
The dose of lenalidomide or fludarabine will be increased from one cohort to the next.
Regardless of the treatment cohort, participants will receive treatment in cycles
lasting 28 days.

- For the first 3-5 days (depending on the group), participants will be treated on an
outpatient basis in the infusion room at the Dana-Farber Clinic, with fludarabine and
rituximab. Fludarabine is given intravenously for 3-5 days. Rituximab is given
intravenously on day 1 of each 28-day cycle. Lenalidomide is given orally once per day
for 3 weeks, followed by 1 week of rest.

- Participants will be monitored very closely during the study treatment. During the
first 28 day period (cycle 1), a physical exam and routine blood tests will be
performed weekly. All participants in a group must finish the first 28-day treatment
period before we proceed with the next group. Once started on study treatment,
participants will continue for six cycles (a cycle is 28 days) of combination therapy
with all three drugs. During that period they will have a physical exam and routine
blood tests on day 1 of each treatment cycle, and additional blood tests on day 15 of
each cycle.

- When participants complete 6 cycles of combination therapy, they will proceed with two
additional months of the lenalidomide alone, for 21 out of 28 days.

- Disease response will be evaluated after 2, 6, and 8 months of study treatment. The
following tests and procedures will be performed: Physical exam; blood tests; CT scans
to evaluate lymph nodes; skin testing; and bone marrow biopsy if all other tests show
no evidence of any remaining CLL and if the baseline bone marrow biopsy was positive

- Participants will have a physical exam and lab work every 3 months as long as their
disease remains in remission.

Inclusion Criteria:

- 18 years of age or older

- Diagnosed with B-CLL/SLL based on the standard histologic and immunophenotypic
criteria described in the WHO classification

- No prior systemic therapy for CLL/SLL, including chemotherapy or antibody therapy

- Currently needs therapy based on 1996 NCI-WG criteria

- Measurable disease

- ECOG Performance Status of 0-2

- Laboratory test results within parameters outlined in protocol

- Able to take aspirin daily as prophylactic anticoagulation

Exclusion Criteria:

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

- Pregnant or breast-feeding females

- Any condition, including the presence of abnormal laboratory abnormalities, which
places the subject at unacceptable risk if he/she were to participate in the study

- Use of any other experimental drug or therapy within 28 days of baseline

- Known hypersensitivity to thalidomide

- Development of erythema nodosum characterized by a desquamating rash while taking
thalidomide or similar drugs

- Prior use of lenalidomide

- Concurrent use of other anti-cancer agents or treatments

- Known positive for HIV

- Chronic active Hep B patients not on prophylactic lamivudine

- Diagnosis of Mantle Cell Lymphoma

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the safety of lenalidomide in combination with fludarabine-rituximab (FR) and to determine the maximum tolerated dose in subjects with previously untreated CLL/SLL.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jennifer R. Brown, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2007

Completion Date:

December 2012

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Leukemia
  • CLL
  • SLL
  • Revlimid
  • lenalidomide
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617