Phase 2 Leukaemia Trial, Recruiting NCT06680661 Sponsor: Leland Metheny Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06680661
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 aged 18 to 70 years old with certain blood cancers or bone marrow disorders, including specific types of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS), mixed-type acute leukemia, chronic myelogenous leukemia (CML) in a second chronic phase, chronic myelomonocytic leukemia (CMML), or relapsed/refractory Hodgkin's lymphoma — each with specific disease stage requirements (confirm with trial site).
  • People who do not have a suitable matched donor available (related or unrelated) for a stem cell transplant.
  • People for whom at least two cord blood units are available that meet specific cell count and tissue-matching requirements, plus at least one backup cord blood unit.
  • People who are well enough to function at a certain level of physical ability — scored at 80 or above on a standard health scale for one treatment regimen, or above 60 for another (confirm with trial site).
  • People who have been in remission in the central nervous system (brain and spinal fluid) at the time of joining, if there was a history of cancer spreading there.
  • People who are able to understand and willing to sign a written consent form.
  • Women who could potentially become pregnant must agree to use highly effective contraception (with a failure rate of less than 1% per year) or remain abstinent during treatment and for 12 months after the last dose of a study medication called abatacept.
  • Men must agree to use a condom plus an additional highly effective contraceptive method, or remain abstinent, during treatment and for 12 months after the last dose of abatacept, and must agree not to donate sperm during this time.

Who may not be able to join:

  • People whose kidneys, liver, lungs, or heart are not functioning well enough — including poor kidney filtration, elevated liver enzymes or bilirubin levels, reduced lung capacity, or a weakened heart pump function (confirm specific thresholds with trial site).
  • People with uncontrolled or active infections, uncontrolled heart failure, unstable chest pain, irregular heart rhythms, or mental health or personal circumstances that would make it difficult to follow the study requirements.
  • Women who are pregnant or breastfeeding, due to the significant risks the chemotherapy used in this trial poses to a developing baby.
  • People with any other condition that, in the treating doctor's judgement, would interfere with safe participation in the trial or make study results difficult to interpret.
  • People with known allergies or intolerances to any of the medications used in this study.
  • People whose immune system has developed specific antibodies against the cord blood unit intended for their transplant.
  • People with a transplant-related health burden score greater than 5 on a standard medical assessment tool (the HCT-CI).
  • People who have had a stem cell transplant (either their own cells or a donor's) within the past 12 months.

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 21 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: Leland Metheny, MD, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Phone: 216-844-0139

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
Leland Metheny
Registry
ClinicalTrials.gov
Start date
25 February 2025
Est. completion
29 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Severe aGVHD free survival

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: 21 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