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Cancer Vaccine

Vaccine Therapy for Lymphoma

Phase 1

Waitlist Available

Led By Sheeba Thomas

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

Tissue diagnosis of lymphoplasmacytic lymphoma with surface immunoglobulin G (IgG), immunoglobulin A (IgA) or immunoglobulin M (IgM) phenotype with a monoclonal heavy and light chain as determined by flow cytometry; all primary diagnostic lymph node and/or bone marrow biopsies will be reviewed at the University of Texas M.D. Anderson Cancer Center (UTMDACC)

Patients must provide a lymph node sample of at least 1.5 cm in the long axis, or a bone marrow aspiration sample providing at least 5 million cluster of differentiation (CD)20 and/or CD38+ (approximately 10 ml)

Must not have

Patients with positive antinuclear antibody (ANA) and/or anti-double strand (ds) DNA antibodies

Patients with New York Heart Association class 3 or 4 disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a cancer vaccine to see if it is safe and effective. The vaccine is made from a person's cancer cells.

Who is the study for?

This trial is for patients with lymphoplasmacytic lymphoma who haven't been treated before. They need a specific type of tumor sample, normal liver function tests, and no severe heart or autoimmune diseases. Participants must be able to consent and follow up, have good physical functioning, and use birth control if necessary.

What is being tested?

The study is testing a vaccine made from the patient's own cancer cells to see if it can trigger the body's immune system to fight the cancer. It also involves checking biomarkers in the lab to understand how well the vaccine works.

What are the potential side effects?

As this is an early-phase trial focusing on dosage and safety, potential side effects are being studied but may include typical vaccine reactions like soreness at injection site, fever, fatigue or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma diagnosis was confirmed with specific tests for IgG, IgA, or IgM.

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I can provide a large enough lymph node sample or a bone marrow sample with enough CD20 or CD38+ cells.

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I have lymphoplasmacytic lymphoma and haven't been treated yet.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidney function is within the required range.

Exclusion Criteria

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

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I have positive ANA or anti-dsDNA antibodies.

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My heart condition severely limits my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity according to the National Cancer Institute Common Toxicity Criteria version 4.0

Secondary study objectives

Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells