Phase 2 Lymphoma Trial, Recruiting NCT04065399 Sponsor: Syndax Pharmaceuticals Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT04065399
Recruiting Phase 2 🇦🇺 Australian site

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.

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 27 July 2026
Phase 2: approximately ~30% 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: Angela R Smith, M.D., Syndax Pharmaceuticals

Phone: 781-419-1400

Australian sites

Peter MacCallum Cancer Centre (PMCC), Melbourne, Victoria
Royal Melbourne Hospital (RMH), Parkville, Victoria
Alfred Hospital, Melbourne,
Sir Charles Gairdner Hospital, Nedlands,
Royal North Shore Hospital, Saint Leonards,

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 2
Sponsor
Syndax Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
5 November 2019
Est. completion
15 December 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇱🇹 Lithuania 🇳🇱 Netherlands Puerto Rico 🇪🇸 Spain 🇺🇸 United States

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?

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: 27 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