Lenalidomide + Rituximab for Chronic Lymphocytic Leukemia

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: HIV, Hepatitis B/C, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 cycles (approximately 12 months)

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alessandra Ferrajoli, MD,BS

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lenalidomide and rituximab in 28-day cycles. Rituximab is administered weekly during Cycle 1, not given in Cycle 2, and then on Day 1 of Cycles 3-12. Lenalidomide is taken daily starting Day 9 of Cycle 1.

12 cycles (approximately 12 months)

Weekly visits during Cycle 1, then every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment. Bone marrow biopsy and aspiration are performed at the end of Cycles 3, 6, and 12.

6 months

Visits at the end of Cycles 3, 6, and 12

Extension

Participants may continue treatment beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response.

Indefinite, based on response

Treatment Details

Interventions

• Lenalidomide
• Rituximab

Trial Overview 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.

Participant Groups

Group I: Untreated 65 + Experimental Treatment 2 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 Age Experimental Treatment 2 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.

Lenalidomide is already approved in European Union, United States for the following indications:

Approved in European Union as Revlimid for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma

Approved in United States as Revlimid for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University