Phase 2 Leukaemia Trial, Recruiting NCT04644016 Sponsor: Memorial Sloan Kettering Cancer Center Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT04644016
Recruiting Phase 2

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 are 21 years old or younger and do not have a suitable matched donor available within the needed timeframe
  • You have been diagnosed with Acute Myeloid Leukemia (AML) that is in first or second remission, or has come back or not responded to treatment with very few cancer cells remaining in the bone marrow
  • You have been diagnosed with Acute Lymphoblastic Leukemia (ALL) that is in first or second remission, or has not responded well even after certain advanced treatments
  • You have another type of acute leukemia (such as a rare type called blastic plasmacytoid dendritic cell neoplasm) with very few cancer cells detected
  • You have a bone marrow condition called Myelodysplastic Syndrome (MDS) or a related blood disorder (but not myelofibrosis) that is considered intermediate-to-high risk, causes serious blood count problems, or has features that suggest a high chance of turning into leukemia
  • You have Non-Hodgkin or Hodgkin Lymphoma that is at high risk of coming back, and your disease meets specific criteria depending on the type (confirm with trial site)
  • You have certain inherited metabolic disorders, including Hurler Syndrome, Hunter Syndrome (early stage), Sly Syndrome, Alpha-Mannosidosis, X-linked Adrenoleukodystrophy, Osteopetrosis, Metachromatic Leukodystrophy, or Globoid Cell Leukodystrophy, generally before significant neurological symptoms develop
  • You have a non-cancerous blood or immune system condition, such as a hemoglobin disorder (like sickle cell disease), bone marrow failure, or an immune deficiency (including HLH)
  • Your overall physical health and ability to perform daily activities meets a minimum score on a standard medical scale (Karnofsky or Lansky score of 70% or above)
  • Your liver, lungs, heart, and kidneys are all functioning well enough to meet specific minimum levels (confirm exact values with trial site)
  • A suitable cord blood unit is available that meets the matching and cell count requirements for your specific condition

Who may not be able to join:

  • Your overall health or organ function is not good enough to safely undergo the treatment
  • You have an advanced metabolic disease as defined by specialist transplant guidelines (confirm with trial site)
  • Leukemia is currently active in your central nervous system (brain or spinal fluid)
  • You have an indolent (slow-growing) form of Non-Hodgkin Lymphoma or Hodgkin Lymphoma that got worse after your most recent treatment
  • You have been diagnosed with myelofibrosis or another cancer involving significant scarring of the bone marrow
  • You have had an autologous stem cell transplant (using your own cells) in the past 6 months
  • You have ever had an allogeneic stem cell transplant (using someone else's cells) at any point in the past
  • You currently have an active infection (bacterial, fungal, or viral) that is not under control
  • You are living with HIV
  • You test positive for a virus called HTLV-1
  • You are currently pregnant or breastfeeding
  • You or your guardian are unable to give informed consent or are unable to follow the full treatment plan, follow-up schedule, and research requirements

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 5 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: Maria Cancio, MD, Memorial Sloan Kettering Cancer Center

Phone: 212-639-2446

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
Registry
ClinicalTrials.gov
Start date
20 November 2020
Est. completion
20 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Treatment related mortality at 1 year after myeloablative cord transplant

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: 5 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