Phase 3 Lymphoma Trial, Recruiting NCT07223021 Sponsor: Memorial Sloan Kettering Cancer Center Condition: Lymphoma
Back to Lymphoma

Phase 3 Lymphoma Trial, Recruiting

NCT07223021
Recruiting Phase 3

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 diagnosed with B-cell acute lymphoblastic leukaemia (B-ALL) who are considered eligible to receive the commercially available treatment tisagenlecleucel.
  • People who weigh more than 9 kilograms at the time of the pre-treatment chemotherapy (called lymphodepleting chemotherapy).
  • People whose liver is working well enough at the time of pre-treatment chemotherapy, based on specific blood test results for liver function (confirm with trial site).
  • People whose kidneys are filtering blood at an adequate rate, calculated using a specific formula based on height and a blood test result (confirm with trial site).
  • People whose heart is pumping at least 50% of its normal capacity, confirmed by a heart scan done within 6 weeks of screening.
  • People whose blood oxygen level is at least 90% when breathing normal room air, as measured by a finger sensor.
  • People aged 16 and over who meet a standard activity and health score (ECOG ≤ 1 or Karnofsky above 60%) at the time of treatment.
  • People under 16 years old who meet a child-specific activity and health score (Lansky 60% or above) at the time of treatment.
  • People (or their parent or legal guardian) who are willing to take part as a research subject and provide written consent before any study procedures begin, in line with local laws.

Who may not be able to join:

  • People with a known allergic or adverse reaction to any of the study drugs or related substances, including fludarabine, cyclophosphamide, or tisagenlecleucel.
  • People whose manufactured tisagenlecleucel product does not meet the required quality standards (referred to as "out of specification").
  • People who have a significant active infection that is not under control, confirmed by clinical signs, imaging, or laboratory tests such as blood cultures or other testing.
  • People (or their parent or guardian) who are unable to give informed consent or are unable to follow the treatment plan as required by the study.
  • People who are pregnant or currently breastfeeding.

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 19 July 2026
Phase 3: approximately ~65% 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: Kevin Curran, MD, Memorial Sloan Kettering Cancer Center

Phone: 1-833-MSK-KIDS

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 3
Registry
ClinicalTrials.gov
Start date
20 October 2025
Est. completion
1 October 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

compare the event free survival (EFS )

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: 19 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