Phase 1 Lymphoma Trial, Recruiting NCT07295951 Sponsor: Janssen Research & Development, LLC Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT07295951
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:

  • People who weigh at least 40 kilograms (about 88 pounds)
  • People who have acute leukemia that has come back or stopped responding to treatment, and whose leukemia has a specific change in one of these genes: KMT2A, NPM1, NUP98, or NUP214 — and for whom other treatment options have been tried or are not suitable
  • People who are generally able to carry out daily activities with little to no limitation (measured by a standard health scale called ECOG grade 0 or 1)
  • People who have regular bowel movements, meaning at least one bowel movement every two days on average
  • Women who could become pregnant must have a negative pregnancy blood test at the start of the trial and again within 48 hours before the first dose of the study treatment

Who may not be able to join:

  • People who have a specific type of leukemia called acute promyelocytic leukemia, or leukemia linked to Down syndrome (as defined by WHO 2016 guidelines)
  • People who have active disease affecting the brain or spinal cord
  • People who have previously received a solid organ transplant (such as a kidney, liver, or heart transplant)
  • People who still have significant side effects from previous cancer treatments that have not returned to their normal baseline or reduced to a mild level — with the exception of hair loss, stable nerve symptoms, or certain low blood count issues
  • People who have had a major operation requiring general anaesthesia within the two weeks before the first dose, who have not yet recovered from a recent major surgery, or who have a major surgery planned during the time the study treatment would be given

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 7 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: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

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
Registry
ClinicalTrials.gov
Start date
18 November 2025
Est. completion
14 June 2026

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Percentage of Dose Excreted in Urine (feu); Percentage of Dose Excreted in Feces (fef); Amount Excreted in Urine (Aeu); Amount Excreted in Feces (Aef); Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t); Maximum Observed Concentration (Cmax)

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: 7 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