Study Stopped
lack of efficacy and tolerability
Dose Escalation Study of Revlimid With Fludarabine-Rituximab for CLL/SLL
A Phase I Dose Escalation Study of Lenalidomide (Revlimid) in Combination With Fludarabine-Rituximab (Rituxan) for Previously Untreated CLL/SLL
2 other identifiers
interventional
9
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2007
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 10, 2007
CompletedFirst Posted
Study publicly available on registry
October 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 27, 2016
May 1, 2016
1.7 years
October 10, 2007
May 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 years
Secondary Outcomes (3)
To determine the objective response rate and progression-free survival following lenalidomide/FR in this patient population
2 years
To determine the improvement in ORR following two months of consolidation lenalidomide after completion of combination therapy
2 years
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.
2 years
Study Arms (1)
Lenalidomide, fludarabine and rituximab
EXPERIMENTALLenalidomide-Dose level will depend upon time the participant enrolls on the study: Given orally once a day for 3 weeks followed by a one week rest period fludarabine- Dose level will vary depending upon when participant enters the trial: Given intravenously for 3-5 days Rituximab- Given intravenously on Day 1 of each 28 day cycle
Interventions
Dose level will depend upon time the participant enrolls on the study: Given orally once a day for 3 weeks followed by a one week rest period
Dose level will vary depending upon when participant enters the trial: Given intravenously for 3-5 days
Given intravenously on Day 1 of each 28 day cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Celgene Corporationcollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer R. Brown, MD, PhD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
October 10, 2007
First Posted
October 12, 2007
Study Start
October 1, 2007
Primary Completion
June 1, 2009
Study Completion
December 1, 2012
Last Updated
May 27, 2016
Record last verified: 2016-05