Phase 2 Lymphoma Trial, Recruiting
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 have active acute leukemia with cancer cells detected in your bone marrow or blood, or a specific type of leukemia with certain genetic changes (KMT2A rearrangement, NUP98 rearrangement, or NPM1 mutation) with detectable disease in the bone marrow.
- For Phase 2, your leukemia has come back or stopped responding to previous treatment, and you fall into one of several groups based on your leukemia type and genetic changes (confirm specific group with trial site).
- Your white blood cell count is below 25,000 per microliter at the time of joining (a medication to lower this count may be given beforehand if needed).
- You are at least 30 days old; if you are joining the part of the study involving a drug called cobicistat, you must weigh at least 35 kg; if joining a specific group called Cohort 2D, you must be at least 18 years old and weigh at least 40 kg.
- You are generally well enough to carry out some daily activities, as measured by a standard health scoring system (confirm details with trial site).
- Any side effects from previous treatments have mostly gone away before joining the study.
- Enough time has passed since your last cancer treatments, including radiation, stem cell transplant, immunotherapy, anti-leukemia therapy, growth factor therapy, or steroids — the required waiting periods vary depending on the treatment type (confirm specific timeframes with trial site).
- Your liver, kidneys, and other organs are working well enough (confirm details with trial site).
- If you are able to become pregnant, you are willing to use a reliable form of birth control from the time you join until 120 days after your last dose of the study drug.
Who may not be able to join:
- You have a specific type of leukemia called acute promyelocytic leukemia.
- Your leukemia has only come back outside of the bone marrow (for certain Phase 2 groups only).
- You have active leukemia affecting your brain or spinal cord.
- You have a detectable level of HIV in your blood within the past 6 months, or a known history of HIV that has not been tested before joining.
- You have active Hepatitis B or C.
- You are pregnant or currently breastfeeding.
- You have had a serious heart event (such as a heart attack, heart failure, or stroke) in the past 6 months, have an uncontrolled heart rhythm problem, or have an abnormal heart electrical reading above a certain level (confirm details with trial site).
- You have a stomach or digestive condition that could affect how you absorb medication taken by mouth (such as gastric bypass surgery or gastroparesis), or you have advanced liver scarring (cirrhosis) of a certain severity.
- You are experiencing symptoms of graft-versus-host disease (a complication that can occur after a stem cell transplant) or have been on immune-suppressing medications within the past 4 weeks.
- You have had another type of cancer in the past 2 years, with some exceptions for certain minor or low-risk cancers that have been successfully treated (confirm details with trial site).
- You are currently taking medications that are known to affect heart rhythm in a certain way, with some exceptions for standard supportive medications (confirm with trial site).
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.
Contact this trial
Principal Investigator: Angela R Smith, M.D., Syndax Pharmaceuticals
Phone: 781-419-1400
Australian sites
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
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of participants with dose-limiting toxicities (DLTs) (Phase 1); Number of participants with treatment-emergent adverse events (TEAEs) (Phase 1); Cmax (Phase 1); Tmax (Phase 1); AUC0-t (Phase 1); CR+CRh rate (Phase 2 [Cohorts 2A-2C]); Number of participants with TEAEs (Phase 2 [Cohorts 2A-2C]); Cmax (Phase 2 [Cohort 2D]); AUC0-tau (Phase 2 [Cohort 2D])
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.