Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I Dose Escalation Study of Lenalidomide (Revlimid) in Combination With Fludarabine-Rituximab (Rituxan) for Previously Untreated CLL/SLL
The purpose of this study is to determine the safety of lenalidomide (revlimid) in combination with fludarabine and rituximab and to determine the highest dose of lenalidomide that can safely be given in that combination. Lenalidomide is a drug that alters the immune system and may also interfere with the the development of tiny blood vessels that help support tumor growth. Lenalidomide is approved by the FDA for the treatment of two different blood cancers called myelodysplastic syndrome and multiple myeloma. Lenalidomide has also been studied in subjects with relapsed CLL. In this research study we are adding lenalidomide to a well-established initial therapy for 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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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