Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 70 years old.
• People with certain types of large B-cell lymphoma who are receiving an autologous stem cell transplant (a transplant using the patient's own stem cells) or an FDA-approved CAR T-cell therapy (a specialised immune cell treatment). The specific lymphoma types include: aggressive double or triple hit lymphoma with certain gene changes; large B-cell lymphoma that has spread to the brain or spinal cord; lymphoma that has transformed from a slower-growing type (such as follicular lymphoma, CLL, or a related condition); or lymphoma with a high-risk score of 4 or 5 on a standard risk scale at diagnosis or before CAR T-cell treatment collection.
• People with large B-cell lymphoma who are receiving an allogeneic stem cell transplant (a transplant using donor stem cells).
• People whose cancer showed at least a partial response (meaning it reduced) or a complete response (meaning it was no longer detectable) before their stem cell transplant, or after their CAR T-cell therapy scan taken 1 to 3 months after treatment.
• People who received a reduced-intensity conditioning regimen before their transplant (a lower-dose preparation treatment before transplant).
• People enrolling no later than 90 days after a stem cell transplant, or no later than 104 days after CAR T-cell therapy.
• People who are well enough to carry out everyday activities, as measured by a standard physical function scale (ECOG score of 0, 1, or 2).
• People whose blood counts and organ function meet minimum levels required by the trial, including sufficient white blood cells, platelets, red blood cells, liver function, and kidney function (confirm specific values with the trial site).
• People who are able to swallow capsules and tablets without difficulty.
• People who are able to give full informed consent and are willing to participate in all study procedures.
• Women of childbearing potential who agree to use highly effective contraception during the study and for 2 days after the last dose of the study drug.

Who may not be able to join:

• People who received a cord blood donor transplant.
• People with significant heart failure classified as Class III or IV by standard heart function criteria, or with a heart pumping function below 50%.
• People with severely reduced kidney function (estimated filtration rate below 30 mL/min).
• People who need ongoing use of certain strong antifungal or other medications that interact with the study drug, and for whom an alternative medication cannot be substituted.
• People with moderate to severe graft-versus-host disease (a complication where donor cells attack the body) at the time of enrolment.
• People who received a red blood cell transfusion within the past 2 weeks, or a platelet transfusion within the past week.
• People with an active serious fungal infection, or an active bacterial or viral infection that has not yet resolved.
• People with a history of or ongoing a serious brain condition called progressive multifocal leukoencephalopathy (PML).
• People who received another experimental drug within 30 days (or within 5 half-lives of that drug, whichever is shorter) before starting the study drug.
• People who had major surgery within 30 days before the first dose of the study drug and have not sufficiently recovered.
• People who have significant problems absorbing medication, such as severe nausea and vomiting, certain bowel conditions, a history of gastric bypass or similar surgery, bowel obstruction, or major bowel removal surgery.
• People who received a live virus vaccine within 28 days before the first dose of the study drug.
• People with a known history of HIV infection.
• People with a history of bleeding disorders such as haemophilia or von Willebrand disease.
• People who are taking warfarin or similar blood-thinning medications.
• People who require treatment with certain strong medications that interact with the study drug (strong CYP3A inhibitors within 1 week, or strong CYP3A inducers within 3 weeks, of starting the study drug).
• People who are pregnant or breastfeeding.
• People who are currently participating in another clinical trial involving a treatment.

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