Combination of Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL)
2 other identifiers
interventional
120
1 country
1
Brief Summary
The goal of this clinical research study is to learn if the combination of lenalidomide and rituximab can help to control CLL. The safety of this drug combination will also be studied. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells. Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 leukemia
Started Dec 2011
Longer than P75 for phase_2 leukemia
1 active site
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
First Submitted
Initial submission to the registry
October 3, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedStudy Start
First participant enrolled
December 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
January 27, 2026
January 1, 2026
14.6 years
October 3, 2011
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Participants evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] overall response criteria by 6 months of treatment. Bone marrow biopsy and aspiration to check the status of the disease. Responses assessed after 3, 6 and 12 cycles.
6 months
Study Arms (2)
Untreated 65 +
EXPERIMENTALPatients with untreated SLL/CLL with indications for treatment that are age 65 or older. Rituximab (375 mg/m2) will be given intravenously on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. Lenalidomide will be started on Day 9 of cycle 1 at the dose of 10 mg/day and will be continued daily. Treatment duration will be 12 cycles and it will be possible to continue beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response.
Prior Treatment Any Age
EXPERIMENTALPatients of any age with previously treated CLL/SLL and recurrent disease. Rituximab (375 mg/m2) will be given intravenously on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. Lenalidomide will be started on Day 9 of cycle 1 at the dose of 10 mg/day and will be continued daily. Treatment duration will be 12 cycles and it will be possible to continue beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response.
Interventions
375 mg/m2 by vein on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2.
10 mg/day by mouth daily beginning on Day 9 of cycle 1.
Eligibility Criteria
You may qualify if:
- Age \>/-18 at the time of signing of informed consent.Understand and voluntarily sign informed consent.
- Patients with chronic lymphocytic leukemia and untreated disease with indication for treatment that are not candidates or unwilling to receive chemoimmunotherapy, or patients of any age with previously treated CLL/SLL or recurrent disease. Patients with recurrent disease are eligible if they have received prior treatment with purine analog based chemotherapy or chemoimmunotherapy or bendamustine.
- ECOG/WHO performance status of 0-2.
- Adequate renal function indicated by serum creatinine less or equal to 2mg/dL
- Adequate hepatic function indicated as total bilirubin less or equal to 2mg/dL and ALT less or equal to 2 times the upper limit of normal.
- Disease free of prior malignancies for 3 years with exception of current basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in this study as long as they have a reasonable expectation to have been cured with the treatment modality received.
- All study participants must be registered into the mandatory RevAssist program and be willing and able to comply with the program requirements.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1. Prescriptions must be filled within 7 days and must either commit to continued abstinence from heterosexual intercourse or use two acceptable methods of birth control, one highly effective method and one additional effective method at the same time at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
You may not qualify if:
- Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab.
- Documented prolymphocytic leukemia (prolymphocytes more than 55% in the peripheral blood).
- Known positivity for HIV or active hepatitis B or C.
- Pregnant or breast feeding females.
- History of tuberculosis treated within the last five years or recent exposure to tuberculosis.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
- Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months prior to enrollment are not eligible for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Celgene Corporationcollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Strati P, Takahashi K, Peterson CB, Keating MJ, Thompson PA, Daver NG, Jain N, Burger JA, Estrov Z, O'Brien SM, Kantarjian HM, Wierda WG, Futreal PA, Ferrajoli A. Efficacy and predictors of response of lenalidomide and rituximab in patients with treatment-naive and relapsed CLL. Blood Adv. 2019 May 14;3(9):1533-1539. doi: 10.1182/bloodadvances.2019031336.
PMID: 31076409DERIVEDTakahashi K, Hu B, Wang F, Yan Y, Kim E, Vitale C, Patel KP, Strati P, Gumbs C, Little L, Tippen S, Song X, Zhang J, Jain N, Thompson P, Garcia-Manero G, Kantarjian H, Estrov Z, Do KA, Keating M, Burger JA, Wierda WG, Futreal PA, Ferrajoli A. Clinical implications of cancer gene mutations in patients with chronic lymphocytic leukemia treated with lenalidomide. Blood. 2018 Apr 19;131(16):1820-1832. doi: 10.1182/blood-2017-11-817296. Epub 2018 Jan 22.
PMID: 29358183DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandra Ferrajoli, MD,BS
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2011
First Posted
October 5, 2011
Study Start
December 12, 2011
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
January 27, 2026
Record last verified: 2026-01