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 who are willing to take part voluntarily, understand what the study involves, and sign a consent form agreeing to follow all trial procedures.
• People who have been confirmed by laboratory testing of tissue samples to have extranodal NK/T-cell lymphoma, nasal type (a specific type of lymphoma) — as diagnosed by the study centre.
• People whose lymphoma has come back or stopped responding to treatment that included asparaginase-based chemotherapy, with or without radiotherapy. (For the second phase of the trial, people must also have previously received a type of immunotherapy called an anti-PD-1 antibody and still not be responding to treatment.)
• People who have at least one area of lymphoma that can be measured or detected on a scan, according to specific imaging guidelines.
• People aged 18 or older at the time of signing the consent form.
• People with a life expectancy of more than 12 weeks.
• People who are reasonably physically functional — able to carry out daily activities with at most some limitation (confirm with trial site for exact definition).
• People whose blood cell counts, liver, kidney, and clotting function meet certain minimum levels, without having needed a blood transfusion or certain blood-boosting treatments in the 14 days before testing.
• People whose heart is pumping at a sufficient level, as measured by an echocardiogram (heart ultrasound).
• People who have recovered from most side effects of previous cancer treatments, with only minor or stable effects remaining.
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before joining, and both women who could become pregnant and men whose partners could become pregnant must agree to use effective contraception from signing the consent form until at least 6 months after the last dose of the study treatment.

Who may not be able to join:

• People who have had another cancer diagnosis within the past 5 years, unless it was a type of skin cancer, thyroid cancer, superficial bladder cancer, or an early-stage cancer of the prostate, cervix, or breast that was treated with the aim of curing it.
• People who received a donor stem cell transplant (from another person) within the past 5 years, or who have received one more than 5 years ago but still have active graft-versus-host disease.
• People who received their own stem cells transplanted back (autologous transplant) within the past 3 months.
• People who have previously been treated with certain targeted drugs known as JAK inhibitors, STAT3 inhibitors, or XPO1 inhibitors.
• People currently taking blood-thinning medications (such as warfarin or antiplatelet drugs), or who are unable to stop taking them at least one week before the first dose.
• People who have taken steroid tablets or injections (other than topical, inhaled, or short-term preventive use) or immune-suppressing medicines within 14 days before joining.
• People who have received standard chemotherapy within 14 days before joining.
• People who have received any systemic cancer treatment, including immunotherapy or antibody-based treatments, within 4 weeks before joining.
• People who have had major surgery within 6 weeks, or radiotherapy within 90 days, before joining.
• People who have received a type of radioactive antibody treatment within 10 weeks before joining.
• People who are currently taking part in another clinical trial involving an experimental drug, or who have done so within 30 days before joining.
• People who have received any vaccine (other than a flu vaccine) within 28 days before joining.
• People with active or latent tuberculosis, HIV infection, or AIDS.
• People with active hepatitis B or C, where the virus is still detectable in the blood.
• People with other active viral infections (such as shingles or CMV) that require treatment, or any infection currently being treated with intravenous antibiotics or antiviral medicines.
• People with serious or uncontrolled heart conditions, including significant heart failure, unstable chest pain, a heart attack within the past year, or heart rhythm problems requiring medical intervention.
• People with ongoing side effects from previous treatments that are still rated above a minor level (except hair loss).
• People with ongoing nausea, vomiting, swallowing difficulties, chronic gut conditions, or prior bowel surgery that could affect how the body absorbs the study drug.
• Women who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use contraception.
• People with psychiatric conditions or any other reason that would prevent them from giving informed consent.
• People who the trial investigator considers unsuitable for any other reason.

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