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Immunomodulatory Agent
Lenalidomide + Rituximab for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Alessandra Ferrajoli, MD,BS
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 at the time of signing of informed consent
ECOG/WHO performance status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will study the effectiveness of lenalidomide and rituximab in treating CLL.
Who is the study for?
This trial is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), either untreated and needing treatment but not suitable for chemoimmunotherapy, or those previously treated. Participants must have proper kidney and liver function, be in a stable health condition, not pregnant, willing to follow birth control requirements if applicable, and free from other serious illnesses.Check my eligibility
What is being tested?
The study tests the effectiveness of combining two drugs: Lenalidomide which boosts the immune system and may block blood vessels that support tumor growth; and Rituximab which targets cancer cells to destroy them. The safety of this combination therapy for CLL/SLL is also being evaluated.See study design
What are the potential side effects?
Potential side effects include changes in blood counts leading to increased infection risk, fatigue, allergic reactions due to Rituximab infusion, possible impact on kidney or liver function. Individual experiences with side effects can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself and perform daily activities.
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My kidney function is good, with creatinine at or below 2mg/dL.
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My liver functions, including bilirubin and ALT levels, are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Trial Design
2Treatment groups
Experimental Treatment
Group I: Untreated 65 +Experimental Treatment2 Interventions
Patients 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.
Group II: Prior Treatment Any AgeExperimental Treatment2 Interventions
Patients 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Lenalidomide
2005
Completed Phase 2
~1070
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,394 Total Patients Enrolled
253 Trials studying Lymphoma
32,351 Patients Enrolled for Lymphoma
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,116 Total Patients Enrolled
50 Trials studying Lymphoma
2,935 Patients Enrolled for Lymphoma
Alessandra Ferrajoli, MD,BSPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
3 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I can take care of myself and perform daily activities.My kidney function is good, with creatinine at or below 2mg/dL.My liver functions, including bilirubin and ALT levels, are within normal limits.I am allergic to lenalidomide, thalidomide derivatives, or rituximab.My blood test shows over 55% prolymphocytes, indicating prolymphocytic leukemia.I do not have any serious health issues that would make joining this study unsafe for me.I have not had a blood clot in my legs or lungs in the last 6 months.I have CLL/SLL and need treatment but can't or won't use chemoimmunotherapy, or I've had it before and it's come back.I've been cancer-free for 3 years, except for minor skin cancers or early-stage cervical or breast cancer.I must follow strict birth control and pregnancy testing if I'm of childbearing age and taking lenalidomide.I was treated for tuberculosis in the last 5 years or recently exposed to it.
Research Study Groups:
This trial has the following groups:- Group 1: Prior Treatment Any Age
- Group 2: Untreated 65 +
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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