Phase 2 Leukaemia Trial, Recruiting NCT05436418 Sponsor: National Cancer Institute (NCI) Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT05436418
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:

For the patient receiving the transplant:

  • You have been diagnosed with a specific blood cancer (such as certain types of leukemia, lymphoma, myeloma, or related conditions) that has been confirmed by lab testing and meets specific stage or treatment history requirements (confirm with trial site for your exact diagnosis)
  • You are age 50 or older, OR you are between 18 and 49 years old AND at least one of the following applies: you have had a previous stem cell transplant, you have taken certain antibody-based cancer drugs before, you have significant health conditions alongside your cancer, your general health/ability to function is somewhat reduced, or your doctor considers standard high-intensity transplant preparation too risky for you
  • You have at least one suitable donor available — either a partially matched family member or a fully matched related or unrelated donor
  • Your general health and ability to function day-to-day meets a minimum standard (a score of 70 or higher on a standard health scale)
  • Your heart is pumping well enough (at least 45% efficiency on an ultrasound test)
  • Your lungs are working well enough (at least 50% of expected function on breathing tests)
  • Your kidneys are filtering blood well enough (a minimum level on a standard kidney function calculation)
  • Your liver test results are within acceptable ranges
  • You agree to use highly effective birth control for at least one year after the transplant if there is any chance you could become pregnant or father a child
  • If you could become pregnant, you must have a negative pregnancy test within 7 days before starting the treatment preparation
  • You are willing and able to understand and sign a consent form

For the stem cell donor:

  • If the donor is a family member, they must be at least 12 years old; if they are an unrelated donor, they must be at least 18 years old
  • The donor has been assessed and approved as eligible to donate according to the relevant medical institution's standards
  • The donor (or their parent/legal guardian) is willing and able to sign a consent form

Who may not be able to join:

For the patient receiving the transplant:

  • You are currently taking part in another clinical trial using an experimental treatment, or you have taken an experimental treatment within the last 2 weeks
  • You are currently breastfeeding
  • You have another type of cancer (not a blood cancer, and not a common skin cancer) that has spread to other parts of the body, has come back or is not responding to treatment, cannot be cured, or was treated with the aim of cure within the last 2 years
  • You have had a serious allergic reaction to medicines that are similar to those used in this trial
  • You have another serious, uncontrolled health condition (such as a severe hormone disorder, serious blood clotting problem, major chemical imbalance in your body, active hepatitis infection, or uncontrolled dental infection) that your doctor believes would make a transplant unsafe for you

For the stem cell donor:

  • No specific reasons to exclude a donor have been listed in the trial criteria

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 26 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: Christopher G Kanakry, M.D., National Cancer Institute (NCI)

Phone: (240) 858-3755

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
18 November 2022
Est. completion
25 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Phase II: Evaluate the efficacy of PTCy, at the lowest dose determined for each HLA-matching arm from phase I, as assessed by 1-year GVHD-free relapse-free survival (GRFS) rate.; Phase I: Determine the lowest effective dose of PTCy in combination with sirolimus and mycophenolate mofetil as GVHD prophylaxis after reduced intensity conditioning and PBSCT, as assessed by primary graft failure AND Grade III-IV acute GVHD as ...

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: 26 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