What is the mechanism of action of this treatment?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include Bruton tyrosine kinase (BTK) inhibitors, BCL2 inhibitors, monoclonal antibodies, and purine analogs. BTK inhibitors, such as ibrutinib, block signals that promote cancer cell survival. BCL2 inhibitors, like venetoclax, induce cancer cell death by targeting proteins that prevent apoptosis. Monoclonal antibodies, such as rituximab, bind to specific proteins on cancer cells, marking them for destruction by the immune system. Purine analogs, like fludarabine, interfere with DNA synthesis, inhibiting cancer cell growth. Treatments like Lenalidomide and Vaccine therapy work by blocking blood flow to the cancer (anti-angiogenic) and stimulating the immune system to attack cancer cells (immune stimulation). These mechanisms are crucial for CLL patients as they target the disease through multiple pathways, potentially leading to more effective and durable responses.

What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include therapies like Lenalidomide, which is known for its anti-angiogenic and immune-stimulating effects. Lenalidomide can cause side effects such as cytopenias (low blood cell counts), increased risk of infections, fatigue, and gastrointestinal issues like nausea and diarrhea. Other common treatments for CLL, such as fludarabine-based regimens, can lead to severe neutropenia, infections, autoimmune hemolytic anemia, and long-term myelotoxicity. Bendamustine combined with rituximab (BR) is another option, with side effects including myelosuppression, infections, and infusion-related reactions. Overall, while these treatments can be effective, they come with a range of potential adverse effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Lymphocytic Leukemia (CLL) that involve mechanisms similar to Lenalidomide and Vaccine therapy, which focus on anti-angiogenic and immune stimulation. Lenalidomide itself is an immunomodulatory drug that has been studied for CLL. Additionally, ibrutinib and acalabrutinib, both Bruton tyrosine kinase (BTK) inhibitors, have been approved for CLL and work by modulating the immune system. Venetoclax, a BCL-2 inhibitor, is another approved drug that induces apoptosis in CLL cells. These treatments reflect the ongoing efforts to harness the immune system and inhibit pathways critical for cancer cell survival in CLL.

What other types of research exist?

Promising novel alternatives for CLL treatment in 2024 include Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib; the BCL2 inhibitor venetoclax; and monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab. These agents can be used alone or in combination to improve outcomes. Additionally, allogeneic hematopoietic stem cell transplantation remains a curative option, particularly for patients with high-risk features such as TP53 dysfunction.

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Immunomodulatory Agent

Lenalidomide + Vaccine for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Led By Kerry Rogers

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the World Health Organization (WHO) classification of hematopoietic neoplasms

CLL/SLL cells must demonstrate high-risk genomic features such as Deletion (Del) (17p13.1), Del(11q22.3), complex karyotype, or unmutated immunoglobulin variable heavy chain (IgVH)

Must not have

Patients who have had any treatment for their CLL/SLL prior to entering the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Lenalidomide might cause side effects such as blood clots, fatigue, diarrhea, rash or itching. The vaccine could lead to injection site reactions, fever or chills. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of patients who achieve an antibody response

Secondary study objectives

Serotyping

Change in anti-tumor antibody levels

Change in serum immunoglobulin

+7 more

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: 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Bone Marrow Biopsy

2021

Completed Phase 3

~230

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790

Lenalidomide

2005

Completed Phase 3

~2240

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Lymphocytic Leukemia (CLL) include Bruton tyrosine kinase (BTK) inhibitors, BCL2 inhibitors, monoclonal antibodies, and purine analogs. BTK inhibitors, such as ibrutinib, block signals that promote cancer cell survival. BCL2 inhibitors, like venetoclax, induce cancer cell death by targeting proteins that prevent apoptosis. Monoclonal antibodies, such as rituximab, bind to specific proteins on cancer cells, marking them for destruction by the immune system. Purine analogs, like fludarabine, interfere with DNA synthesis, inhibiting cancer cell growth. Treatments like Lenalidomide and Vaccine therapy work by blocking blood flow to the cancer (anti-angiogenic) and stimulating the immune system to attack cancer cells (immune stimulation). These mechanisms are crucial for CLL patients as they target the disease through multiple pathways, potentially leading to more effective and durable responses.

Targeted therapy in the treatment of chronic lymphocytic leukemia: facts, shortcomings and hopes for the future.New angles of attack in the fight against chronic lymphocytic leukemia: the advent of novel non-chemotherapeutic agents.