Blood cancer Patients' vaccine response under the microscope
NCT ID NCT05170399
First seen Jun 24, 2026 · Last updated Aug 05, 2026 · Updated 8 times
Summary
This study looks at how well vaccines for flu, COVID-19, shingles, hepatitis B, and pneumonia work in people with certain blood cancers like chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphomas. Researchers will measure immune responses through blood samples before and after vaccination. Up to 500 adults will participate, and some may pause their cancer treatment temporarily to see if that improves vaccine effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vaccines (influenza, shingles, pneumococcal, hepatitis B, COVID-19)
- What this could lead to
- If successful, this could help doctors recommend better vaccine schedules for people with blood cancers, potentially improving protection against preventable diseases.
- What could go wrong
- This is an observational study, not testing a new treatment. Results may not apply to all blood cancer patients, and vaccine responses may still be weak in some individuals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2022
- Expected to finish
-
Nov 2036
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 90 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Diagnosis of CLL, FL, MCL, MZL, NHL NOS or WM * Must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: 1. Patients with CLL AND one of the following: i. Arm 1: Must be treatment naive (no prior cancer directed therapy) ii. Arm 2: Patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. Arm 3: Must be receiving treatment with a BTKi. This arm is not available to patients receiving the HEPLISAV-B vaccine iv. Arm 4: Must be receiving treatment with a BTKi for \>= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination. This arm is not available to patients who have had a prior episode of disease flare during periods of drug hold, or for patients with CLL that is actively progressing. v. Arm 5: Must be receiving treatment with a BCL-2 inhibitor Or 2. Patients with FL, MCL, MZL, NHL NOS or WM AND one of the following: i. Arm 1: Must currently not be receiving active treatment (treatment na(SqrRoot) ve or previously treated) ii. Arm 2: Must be receiving treatment with targeted therapies (e.g. BTKi, BCL-2 inhibitors, PI3K inhibitors, immunomodulatory agents, proteasome inhibitors) * If prior exposure to Hepatitis-B vaccination, must have documentation of negative serologic response * Age \>= 18 years * Able to comprehend the investigational nature of the protocol and provide informed consent EXCLUSION CRITERIA: 1. Female patients who are currently pregnant 2. History of severe allergic reaction to vaccines 3. Concomitant inherited immunodeficiency 4. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk. 5. Receive cytotoxic chemotherapy within 2 weeks prior to vaccination 6. Receive intravenous immunoglobulin (IVIG) within 2 months prior to vaccination 7. Receive anti-CD20 and/or anti-CD19 monoclonal antibody therapy within 6 months prior to vaccination 8. Receive cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination 9. History of allogeneic stem cell transplantation
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic lymphocytic leukemia are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Development and pilot implementation of a novel remote patient monitoring program for cancer patients initiating cancer-directed therapy: the SHIELD (Smart health integration for early life-saving detection)
- Can a new BTK inhibitor outsmart resistance in CLL?
- Which lymphoma drug combo works best? a new study aims to find out
- Can a Three-Drug combo erase mantle cell lymphoma without chemotherapy?
- A simple blood draw might reveal hidden eye lymphoma
- Can a new pill outsmart Drug-Resistant leukemia?