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Cancer Vaccine

Vaccines for Blood Cancer

Phase 4

Recruiting

Led By Christopher MT Pleyer, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

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

Must have

Diagnosis of CLL, FL, MCL, MZL, NHL NOS or WM

i. Arm 1: Must be treatment naive (no prior cancer directed therapy)

Must not have

Female patients who are currently pregnant

Concomitant inherited immunodeficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after completing vaccine series

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial is testing how well vaccines work in people with certain types of blood cancers.

Who is the study for?

Adults 18+ with blood cancers like CLL, Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas can join. Participants will choose vaccines for diseases such as COVID-19 and shingles to receive and provide blood samples before and after vaccination. Those on BTKis may need to pause treatment around vaccination.

What is being tested?

The trial is testing how well people with specific blood cancers respond to various vaccines including those for flu, pneumonia, COVID-19, hepatitis B, and shingles. It involves multiple study visits over up to five years with optional booster doses.

What are the potential side effects?

Potential side effects from the vaccines could include soreness at injection site, fever, fatigue, muscle pain, headache or allergic reactions. Specific side effects depend on each vaccine received.

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 a type of non-Hodgkin lymphoma.

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I have not received any treatment for my cancer.

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I have had cancer treatment before but am not on any treatment now.

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I am currently being treated with a BTK inhibitor and not receiving the HEPLISAV-B vaccine.

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I have been diagnosed with a type of non-Hodgkin lymphoma.

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I have not received any treatment for my cancer.

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I have had cancer treatment before but am not on any treatment now.

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I am currently being treated with a BCL-2 inhibitor.

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I have a type of non-Hodgkin lymphoma.

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I am not currently undergoing any cancer treatment.

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I am currently on targeted cancer therapy.

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I have proof of a negative response to the Hepatitis-B vaccine.

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I am 18 years old or older.

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I understand this is a research study and I can give my consent.

Exclusion Criteria

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

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I am currently pregnant.

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I have a genetic condition that weakens my immune system.

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I have not had cellular therapy like CAR-T in the last 12 months.

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I have had a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after completing vaccine series

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks after completing vaccine series

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after completing vaccine series for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Serologic response against each administered vaccine following completion of the vaccine series in each study arm

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

9Treatment groups

Experimental Treatment

Group I: Participants diagnosed with Chronic Lymphocytic Leukemia (CLL)Experimental Treatment12 Interventions

Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, Moderna-COVID-19 and receive assessment of serologic and cellular response following completion of each vaccine series.

Group II: Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted TherapiesExperimental Treatment12 Interventions

Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, and receive assessment of serologic and cellular response following completion of each vaccine series.

Group III: Other Non-Hodgkin Lymphoma and Waldenstrom MacroglobulinemiaExperimental Treatment12 Interventions

Group IV: Follicular Lymphoma Treatment NaiveExperimental Treatment12 Interventions

Group V: Follicular LymphomaExperimental Treatment12 Interventions

Group VI: Chronic Lymphocytic Leukemia Treatment with BTKiExperimental Treatment12 Interventions

Group VII: Chronic Lymphocytic Leukemia Treatment NaiveExperimental Treatment12 Interventions

Group VIII: Chronic Lymphocytic Leukemia Treatment Break for BTKiExperimental Treatment12 Interventions

Group IX: Chronic Lymphocytic Leukemia Not Receiving Active TreatmentExperimental Treatment12 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluarix