What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include chemoimmunotherapy, targeted agents, and immune-stimulating therapies. Chemoimmunotherapy, such as the combination of rituximab and bendamustine, often causes infusion reactions, myelosuppression, and increased risk of infections. Targeted agents like ibrutinib and venetoclax can lead to side effects such as diarrhea, fatigue, and cytopenias. Immune-stimulating therapies, including those involving interleukin-2, may cause flu-like symptoms, fever, fatigue, and injection site reactions. These treatments aim to enhance the body's immune response to target and kill cancer cells but can also lead to immune-related adverse effects.

What prior FDA approvals exist?

The FDA has approved several immunotherapies and targeted therapies for the treatment of Chronic Lymphocytic Leukemia (CLL). Notable approvals include monoclonal antibodies such as rituximab, ofatumumab, and obinutuzumab, which target CD20 on B cells to stimulate the immune system to attack cancer cells. Additionally, targeted agents like ibrutinib and venetoclax have been approved, which inhibit specific proteins involved in CLL cell survival. These treatments, while not identical, share the common goal of enhancing the body's immune response to target and kill cancer cells, similar to the investigational liposome-based vaccine with interleukin-2.

What other types of research exist?

Promising novel alternatives for CLL treatment in 2024 include: 1) CAR T-cell therapy targeting CD19 and CD22, 2) Antibody-based therapeutics such as those targeting CD74, 3) Reduced intensity or nonmyeloablative hematopoietic cell transplantation (HCT), and 4) Targeted drug combinations like venetoclax plus obinutuzumab or ibrutinib-based therapy.

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Cancer Vaccine

Cancer Vaccine for Chronic Lymphocytic Leukemia

Phase 1

Waitlist Available

Led By Shuo Ma, MD, PhD

Research Sponsored by XEME Biopharma Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a special vaccine made from a patient's own cancer cells and an immune booster to treat chronic lymphocytic leukemia. It targets patients who have not been treated before, aiming to help their immune system recognize and destroy cancer cells.

Who is the study for?

Adults with untreated chronic lymphocytic leukemia (CLL) showing disease progression but not severe enough to require immediate treatment. Participants must have a certain level of white blood cells, be in good physical condition, and have normal kidney and liver function. Women who can bear children and sexually active men must use contraception. Those with other cancers, immune diseases, or infections that could affect the trial are excluded.

What is being tested?

The trial is testing a new vaccine therapy called Oncoquest-CLL for CLL patients. It uses liposomes with cancer cell extracts and interleukin-2 to potentially stimulate the body's immune system to attack leukemia cells.

What are the potential side effects?

Possible side effects may include reactions at the injection site, flu-like symptoms such as fever or chills due to immune activation, fatigue from the body's response to treatment, and potential autoimmune responses where the body attacks its own cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility in terms of vaccine delivery.

Feasibility in terms of vaccine production.

Incidence of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Secondary study objectives

Clinical response evaluated using IWCLL2008 guidelines.

In vitro immune response evaluated using T-cell and B-cell immune responses.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oncoquest-CLL vaccine treatmentExperimental Treatment1 Intervention

Patients receive Oncoquest-CLL vaccine subcutaneously on Day 1 and 15, and then monthly for 3 months in the absence of disease progression or unacceptable toxicity.

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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

The most common treatments for Chronic Lymphocytic Leukemia (CLL) include targeted therapies, immunotherapies, and novel agents. Targeted therapies, such as Bruton tyrosine kinase (BTK) inhibitors, work by blocking specific proteins that promote cancer cell survival and proliferation. Immunotherapies, including monoclonal antibodies, enhance the immune system's ability to recognize and destroy cancer cells. Novel agents like the liposome-based vaccine with interleukin-2 stimulate the immune response to target and kill cancer cells. These treatments are crucial for CLL patients as they offer more effective and less toxic alternatives to traditional chemotherapy, improving both survival rates and quality of life.

Targeted therapy in the treatment of chronic lymphocytic leukemia: facts, shortcomings and hopes for the future.Allogeneic Transplantation for Chronic Lymphocytic Leukemia in the Age of Novel Treatment Strategies.Depletion of CLL-associated patrolling monocytes and macrophages controls disease development and repairs immune dysfunction in vivo.