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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Jennifer R. Brown, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|