Phase 3 Lymphoma Trial, Recruiting NCT05976763 Sponsor: Alliance for Clinical Trials in Oncology Condition: Lymphoma
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Phase 3 Lymphoma Trial, Recruiting

NCT05976763
Recruiting Phase 3

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 mantle cell lymphoma (a type of blood cancer), confirmed by laboratory testing of tissue samples showing specific markers or genetic changes linked to this disease — including some rarer forms of mantle cell lymphoma confirmed by other markers (confirm with trial site)
  • People at any stage of the disease (Stage I through IV)
  • People who have at least one area of lymphoma that can be measured on a PET or CT scan
  • People aged 70 or older, OR people aged 60–69 who have certain health conditions that would make a stem cell transplant too risky — such as reduced heart pumping ability, reduced lung function, reduced kidney function, a performance status score of 2, or a high score on a scale measuring overall health burden (confirm with trial site)
  • People who are not considered suitable candidates for a stem cell transplant, or who have chosen not to pursue a stem cell transplant
  • People who have a general health/activity level rated as 0, 1, or 2 on a standard medical scale (meaning they are fully active to capable of self-care but not physically demanding work)
  • People whose blood counts meet minimum thresholds — including white blood cells, platelets, and kidney function — without needing recent medical support to reach those levels
  • People whose liver function tests are within acceptable ranges
  • People living with HIV who are on effective treatment and whose virus is undetectable within the past 6 months
  • People with a past hepatitis B exposure (but no active infection) who are on appropriate preventive antiviral medication and have no detectable virus
  • People with a history of hepatitis C who have no detectable hepatitis C virus in their blood
  • People who have or have had another cancer, as long as that cancer and its treatment are unlikely to interfere with this trial's safety or results (confirm with trial site)
  • People who have recovered from any major surgery before joining

Who may not be able to join:

  • People who have previously received any systemic (whole-body) treatment for mantle cell lymphoma
  • People who have previously received radiation treatment for early-stage (Stage I) mantle cell lymphoma
  • People who have previously been treated with a BTK inhibitor (a type of targeted cancer drug) or an anti-CD20 antibody therapy (another type of cancer drug)
  • People who have previously had a stem cell transplant
  • People who have significant heart problems, including unstable chest pain in the past 3 months, severe heart failure, a history of serious heart rhythm problems, a specific abnormal electrical reading on a heart tracing (unless a pacemaker is in place), or certain types of heart block without a pacemaker
  • People with active hepatitis B or hepatitis C infection
  • People who have recently received a live vaccine within the past 35 days
  • People with a known allergy or sensitivity to the study drugs (zanubrutinib or rituximab) or their ingredients
  • People with a history of serious bleeding disorders such as haemophilia A, haemophilia B, or von Willebrand disease, or a history of spontaneous bleeding that required medical treatment
  • People who have had a stroke or bleeding in the brain within the past 6 months
  • People with significant problems affecting digestion or absorption in the gut — such as removal of part of the stomach or small bowel, certain weight-loss surgeries, active inflammatory bowel disease, or bowel obstruction — or people who are unable to swallow pills
  • People currently taking certain medications that strongly affect how the body processes drugs (known as strong CYP3A4 inhibitors or inducers), unless those medications have been stopped at least 14 days before joining the trial

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 19 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 919-966-9268

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 3
Registry
ClinicalTrials.gov
Start date
20 October 2023
Est. completion
31 August 2038

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression-free survival (PFS) 1 (Arm A); Progression-free survival (PFS) 2 (Arm B)

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: 19 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