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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after completing vaccine series
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with a type of non-Hodgkin lymphoma.
Select...
I have not received any treatment for my cancer.
Select...
I have had cancer treatment before but am not on any treatment now.
Select...
I am currently being treated with a BTK inhibitor and not receiving the HEPLISAV-B vaccine.
Select...
I have been on a BTK inhibitor for over 6 months and can pause it for up to 7 weeks for vaccination.
Select...
You are currently receiving treatment with a BCL-2 inhibitor or you have previously received treatment.
Select...
I have been diagnosed with a type of non-Hodgkin lymphoma.
Select...
I have CLL.
Select...
I have not received any treatment for my cancer.
Select...
I have had cancer treatment before but am not on any treatment now.
Select...
I am currently being treated with a BTK inhibitor and not receiving the HEPLISAV-B vaccine.
Select...
I've been on BTK inhibitor treatment for 6+ months and can pause it for vaccinations, without prior treatment issues.
Select...
I am currently being treated with a BCL-2 inhibitor.
Select...
This criterion does not provide enough information for a summary.
Select...
I have a type of non-Hodgkin lymphoma.
Select...
I am not currently undergoing any cancer treatment.
Select...
I am currently on targeted cancer therapy.
Select...
I have proof of a negative response to the Hepatitis-B vaccine.
Select...
I am 18 years old or older.
Select...
I understand this is a research study and I can give my consent.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serologic response against each administered vaccine following completion of the vaccine series in each study arm
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
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 IV: Follicular Lymphoma Treatment NaiveExperimental 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 V: Follicular LymphomaExperimental 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 VI: Chronic Lymphocytic Leukemia Treatment with BTKiExperimental 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 VII: Chronic Lymphocytic Leukemia Treatment NaiveExperimental 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 VIII: Chronic Lymphocytic Leukemia Treatment Break for BTKiExperimental 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 IX: Chronic Lymphocytic Leukemia Not Receiving Active TreatmentExperimental 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PNEUMOVAX 23
2021
Completed Phase 1
~40
Fluarix
2006
Completed Phase 4
~15180
Afluria
2013
Completed Phase 3
~2840
Flucelvax
2021
Completed Phase 4
~1000
Shingrix
2019
Completed Phase 4
~500
Fluzone
2011
Completed Phase 4
~10500
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,834 Previous Clinical Trials
47,310,135 Total Patients Enrolled
41 Trials studying Lymphoma
7,525 Patients Enrolled for Lymphoma
Christopher MT Pleyer, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
3 Previous Clinical Trials
269 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have CLL.I am currently being treated with a BTK inhibitor and not receiving the HEPLISAV-B vaccine.I've been on BTK inhibitor treatment for 6+ months and can pause it for vaccinations, without prior treatment issues.I have a type of non-Hodgkin lymphoma.I am 18 years old or older.I am not currently undergoing any cancer treatment.You are currently receiving treatment with a BCL-2 inhibitor or you have previously received treatment.I have not had chemotherapy within the last 2 weeks.I have received IVIG treatment within the last 2 months.I have been on a BTK inhibitor for over 6 months and can pause it for up to 7 weeks for vaccination.I have proof of a negative response to the Hepatitis-B vaccine.I have been diagnosed with a type of non-Hodgkin lymphoma.I have a genetic condition that weakens my immune system.I have had a stem cell transplant from a donor.I have had cancer treatment before but am not on any treatment now.I have not received any treatment for my cancer.I have received anti-CD20 or anti-CD19 therapy within the last 6 months.I have been diagnosed with a type of non-Hodgkin lymphoma.I am currently pregnant.You have had a serious allergic reaction to vaccines in the past.I have not received any treatment for my cancer.I have had cancer treatment before but am not on any treatment now.I am currently being treated with a BCL-2 inhibitor.I have not had cellular therapy like CAR-T in the last 12 months.I am currently on targeted cancer therapy.This criterion does not provide enough information for a summary.I understand this is a research study and I can give my consent.I am currently being treated with a BTK inhibitor and not receiving the HEPLISAV-B vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia
- Group 2: Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies
- Group 3: Chronic Lymphocytic Leukemia Not Receiving Active Treatment
- Group 4: Chronic Lymphocytic Leukemia Treatment Break for BTKi
- Group 5: Chronic Lymphocytic Leukemia Treatment Naive
- Group 6: Chronic Lymphocytic Leukemia Treatment with BTKi
- Group 7: Follicular Lymphoma
- Group 8: Follicular Lymphoma Treatment Naive
- Group 9: Participants diagnosed with Chronic Lymphocytic Leukemia (CLL)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment size of this clinical trial?
"Affirmative. Clinicaltrials.gov verifies that this medical trial was initially posted on September 14th 2022 and is continuing to seek new participants at present time. 500 individuals are needed for the study which will take place in one facility."
Answered by AI
Have any prior investigations investigated the efficacy of Heplisav -B?
"Currently, Heplisav -B is the subject of 76 live clinical trials; 20 of them are in Phase 3. In Nantwich, Cheshire, Surrey alone there are several studies looking into this drug and a total of 1054 sites across the world conducting research on it."
Answered by AI
Is there currently an opportunity for enrollment in this medical experiment?
"Affirmative, the details available on clinicaltrials.gov demonstrate that this research project is actively seeking participants. It was first published September 14th 2022 and has been recently updated November 23rd of the same year. In total, 500 individuals are desired for a single location trial."
Answered by AI
To what extent is Heplisav-B a potential hazard for patients?
"Heplisav-B is approved at a safety rating of 3, as the medication has completed Phase 4 trials and thus been deemed suitable for use."
Answered by AI
What illnesses does Heplisav-B provide remedial action for?
"Heplisav-B is commonly administered to treat hepatitis A, and has also proven successful in managing streptococcus pneumoniae infection, traumatic injuries, and viral hepatitis b."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
65+
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- National Institutes of Health Clinical Center: < 48 hours
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