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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 3
~1480

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,232 Total Patients Enrolled
253 Trials studying Lymphoma
32,472 Patients Enrolled for Lymphoma
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,315 Total Patients Enrolled
50 Trials studying Lymphoma
3,134 Patients Enrolled for Lymphoma
Alessandra Ferrajoli, MD,BSPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
3 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01446133 — Phase 2
Lymphoma Research Study Groups: Prior Treatment Any Age, Untreated 65 +
Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT01446133 — Phase 2
Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01446133 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some diseases that Rituximab has been known to improve?

"Rituximab is a medication used to diffuse large b-cell lymphoma (dlbcl), as well as certain other conditions like b-cell lymphomas and polyangium."

Answered by AI

Rituximab: How great is the threat it poses to human health?

"There is some data supporting Rituximab's safety, but none to suggest it is effective. It received a score of 2."

Answered by AI

Are we looking for more participants in this clinical trial at the moment?

"The clinical trial described is not presently looking for subjects. The study was initially posted on December 12, 2011 and was last edited on October 11, 2020. Even though this particular research project isn't happening right now, there are 3578 other trials that are actively recruiting patients."

Answered by AI

How many individuals are part of this clinical trial currently?

"This study is no longer recruiting patients. The listing was created on December 12th, 2011 and last updated on October 11th, 2020. For those looking for other studies, there are 2950 trials related to leukemia and 628 involving Rituximab that are still recruiting participants."

Answered by AI
~7 spots leftby Dec 2024