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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

Must not have

Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab

Documented prolymphocytic leukemia (prolymphocytes more than 55% in the peripheral blood)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to lenalidomide, thalidomide derivatives, or rituximab.

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My blood test shows over 55% prolymphocytes, indicating prolymphocytic leukemia.

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I do not have any serious health issues that would make joining this study unsafe for me.

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I have not had a blood clot in my legs or lungs in the last 6 months.

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I was treated for tuberculosis in the last 5 years or recently exposed to it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2990

Lenalidomide

2005

Completed Phase 3

~2240