Phase 1 Lymphoma Trial, Recruiting NCT06730542 Sponsor: Juan P. Alderuccio, MD Condition: Lymphoma
Back to Lymphoma

Phase 1 Lymphoma Trial, Recruiting

NCT06730542
Recruiting Phase 1

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:

  • You are 18 years of age or older (or the legal adult age in your country)
  • You have been diagnosed with large B-cell lymphoma (a type of blood cancer), confirmed by a tissue sample, including any subtype of this cancer
  • You have at least one measurable area of lymphoma visible on a scan (PET/CT or CT scan)
  • Your lymphoma has spread to both other parts of your body (systemic) AND to your central nervous system — such as the brain, spinal cord, eyes, or related areas
  • The CNS involvement has been confirmed by biopsy, spinal fluid testing, brain scan, or strong medical suspicion by the doctor
  • You are generally able to carry out basic daily activities, or any limitations are due to the lymphoma itself (confirm with trial site)
  • Your doctors expect you to live for at least 3 months or more
  • Your blood counts and organ function (including kidneys, liver, and bone marrow) meet the required levels as measured by blood tests
  • You are able to understand the study requirements and sign a consent form
  • Women who could become pregnant must agree to use highly effective birth control during the study and for 90 days after treatment ends; if using hormonal contraceptives (like the pill), a barrier method (like condoms) must also be used
  • Men whose partners could become pregnant must agree to abstain from sex, be vasectomised, or use barrier contraception during the study and for 90 days after treatment ends

Who may not be able to join:

  • You have lymphoma only in the central nervous system (brain/spinal cord area) with no lymphoma elsewhere in the body
  • You have already received more than one cycle of certain chemotherapy regimens, or more than one dose of a medication injected into the spinal fluid, for your lymphoma (one cycle or one dose may still be allowed — confirm with trial site)
  • You have a serious or uncontrolled heart condition, such as a heart attack in the last 6 months, severe heart failure, dangerous heart rhythm problems, very high blood pressure, or certain abnormal heart electrical readings
  • You have an active autoimmune condition causing your immune system to attack your own blood cells (such as immune thrombocytopenia)
  • You have an uncontrolled serious illness, such as liver cirrhosis, an autoimmune disorder needing long-term steroid treatment, or a serious psychiatric condition
  • You have severe or debilitating lung disease
  • You have another active cancer currently requiring treatment
  • You have been treated for another cancer within the past 3 years (some early-stage or fully cured skin, bladder, cervical, breast, or prostate cancers may still be acceptable — confirm with trial site)
  • You currently have an active infection (fungal, bacterial, or viral) that requires treatment with systemic medicines
  • You are pregnant or breastfeeding
  • You have an active HIV infection with detectable virus, or active hepatitis B or C infection (some cases with undetectable virus levels may still be eligible — confirm with trial site)
  • You are not able to make your own decisions about participating in the study
  • You are currently taking certain strong medications that affect how the body processes the study drug (a class called strong CYP3A inducers — confirm with trial site)
  • You have an underlying medical condition that, in your doctor's opinion, would make taking the study drug unsafe
  • You are unable to swallow capsules, or you have a significant digestive condition that would prevent you from absorbing oral medication properly
  • You have a history of a severe bleeding disorder, such as haemophilia or von Willebrand disease
  • You have had a stroke or bleeding in the brain within the last 180 days (about 6 months)
  • You have had major surgery within 4 weeks before starting the study drug
  • You currently need to take warfarin or similar blood-thinning medications
  • You have received a live vaccine within 28 days before starting the study, or plan to receive one during the study
  • You are allergic to the study drug (zanubrutinib) or any of the other medicines used in this trial
  • You are currently taking part in another clinical treatment 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 5 July 2026
Phase 1: approximately ~10% 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

Principal Investigator: Juan P Alderuccio, MD, University of Miami

Phone: +1 (347) 9312272

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 1
Sponsor
Juan P. Alderuccio, MD
Registry
ClinicalTrials.gov
Start date
17 April 2025
Est. completion
30 April 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants experiencing dose-limiting toxicities (DLTs)

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: 5 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