Dose Escalation Study of Revlimid With Fludarabine-Rituximab for CLL/SLL
Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Lymphocytic Leukemia; Small Lymphocytic Leukemia
Intervention: Lenalidomide (Drug); Fludarabine (Drug); Rituximab (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s): Jennifer R. Brown, MD, PhD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
Summary
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.
Clinical Details
Official title: A Phase I Dose Escalation Study of Lenalidomide (Revlimid) in Combination With Fludarabine-Rituximab (Rituxan) for Previously Untreated CLL/SLL
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: To determine the objective response rate and progression-free survival following lenalidomide/FR in this patient populationTo determine the improvement in ORR following two months of consolidation lenalidomide after completion of combination therapy To assess effects on immune function as measured by cytokine levels, T and NK cell subsets, T cell activation during therapy and DTH vaccine responses.
Detailed description:
- 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: October 2007
Last updated: November 30, 2012
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