Phase 2 Leukaemia Trial, Recruiting NCT06892223 Sponsor: Istituto Clinico Humanitas Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06892223
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:

  • People who are able to give informed consent and are willing to follow all study procedures
  • Adults aged 18 or older, of any gender or race
  • People who have been diagnosed with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or a related blood cancer condition called MDS/MPN
  • People who do not have a fully matched donor and have received a "half-matched" (haploidentical) stem cell transplant, with a specific combination of anti-rejection medications (Cyclophosphamide, Cyclosporine A, and Mycophenolate mofetil) given on particular days after the transplant
  • People who received their half-matched stem cell transplant after a conditioning treatment (a course of therapy to prepare the body for transplant), using either bone marrow or blood stem cells as the graft
  • Women who could become pregnant must have a negative pregnancy test within 8 days before starting the study treatment
  • Women who could become pregnant, and men whose partners could become pregnant, must agree to use a highly effective form of contraception from the time of giving consent until at least 52 weeks after the last dose of study treatment

Who may not be able to join:

  • People under 18 years of age
  • People with an active infection that is not under control
  • People whose AML has spread to the central nervous system (brain and spinal cord)
  • People with a low physical functioning score (below 60% on a standard medical scale) or serious organ problems, including weakened heart function, reduced lung capacity, or poor kidney function (confirm with trial site)
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study
  • People whose cancer comes back rapidly before day 30 after their stem cell transplant
  • People who develop a serious immune reaction called acute Graft-versus-Host Disease (GvHD) before day 30 after their stem cell transplant
  • People who have had a second allogeneic (donor) stem cell transplant

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 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

Phone: +39 02 8224 5157

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
Istituto Clinico Humanitas
Registry
ClinicalTrials.gov
Start date
3 December 2021
Est. completion
1 March 2025

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Graft-versus-host disease-free and progression-free survival (GPFS)

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