Lenalidomide + Vaccine for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen ByKerry Rogers

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This trial studies lenalidomide and a vaccine in patients with early-stage CLL or SLL. Lenalidomide stops cancer growth and boosts the immune system, while the vaccine helps the body fight infections. Together, they aim to improve the body's defense against cancer. Lenalidomide has been extensively studied and used in the treatment of various blood cancers due to its ability to promote tumor cell death and stimulate immune responses.

Eligibility Criteria

This trial is for patients with early-stage, asymptomatic chronic lymphocytic leukemia or small lymphocytic lymphoma who have high-risk genomic features but haven't had previous CLL/SLL treatments. Participants must be in good health with proper organ function and no history of certain conditions like uncontrolled illness or recent deep vein thrombosis.

Inclusion Criteria

I do not meet the criteria for starting treatment based on symptoms or previous therapies for CLL/SLL.

I have been diagnosed with CLL or SLL according to WHO standards.

My CLL/SLL cancer cells show high-risk genetic changes.

Exclusion Criteria

I have received treatment for my CLL/SLL before this study.

I haven't taken corticosteroids in the last two weeks, except for a non-cancer related condition.

Patients receiving other investigational agents

+2 more

Participant Groups

The study tests the combination of lenalidomide, a drug that may inhibit cancer growth and stimulate the immune system, with a pneumococcal vaccine designed to boost the body's ability to fight cancer cells. The goal is to see if this combo can create a stronger immune response against cancer.

2Treatment groups

Experimental Treatment

Group I: Arm B (Sequential PCV13 and lenalidomide)Experimental Treatment6 Interventions

Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024)

Group II: Arm A (Concurrent PCV13 and lenalidomide)Experimental Treatment6 Interventions

Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024)

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

🇪🇺 Approved in European Union as Revlimid for: