Phase 4 Lymphoma Trial, Recruiting NCT05170399 Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Condition: Lymphoma
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Phase 4 Lymphoma Trial, Recruiting

NCT05170399
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with chronic lymphocytic leukaemia (CLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), non-Hodgkin lymphoma (NHL, not otherwise specified), or Waldenström's macroglobulinaemia (WM)
  • People with CLL who fit into one of these groups: have never received cancer treatment; have had prior cancer treatment but are not currently being treated; are currently taking a type of medication called a BTK inhibitor; have been on a BTK inhibitor for 6 months or more and are willing to pause that medication for up to 7 weeks around each vaccination (this option is not available to those whose disease was actively getting worse during a previous medication pause); or are currently taking a type of medication called a BCL-2 inhibitor
  • People with FL, MCL, MZL, NHL (not otherwise specified), or WM who are either not currently receiving any active cancer treatment, or who are currently receiving certain targeted therapies (such as BTK inhibitors, BCL-2 inhibitors, or similar medicines)
  • People who have previously received a Hepatitis B vaccine must have documentation showing that the vaccine did not produce a positive immune response
  • People aged 18 years or older
  • People who are able to understand the nature of the study and provide written consent to participate

Who may not be able to join:

  • People who are currently pregnant
  • People who have had a severe allergic reaction to a vaccine in the past
  • People who have an inherited condition that affects the immune system
  • People with a serious illness or medical condition that, in the treating doctor's opinion, could put their safety or the study's results at risk
  • People who have received cytotoxic chemotherapy within 2 weeks before vaccination
  • People who have received intravenous immunoglobulin (IVIG) within 2 months before vaccination
  • People who have received certain antibody treatments targeting CD20 or CD19 within 6 months before vaccination
  • People who have received cellular therapy (such as CAR-T cell therapy) within 12 months before vaccination
  • People who have previously had an allogeneic stem cell transplant (a transplant using stem cells from another person)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Adrian U Wiestner, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Phone: (301) 827-1094

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
14 September 2022
Est. completion
16 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov