Combining an unmodified family (haplo‑identical) donor graft with cord blood for transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients who lack HLA‑matched adult donors will receive an unmodified haplo‑identical graft with post‑transplant cyclophosphamide for acute GVHD prevention, and then a cord blood graft will be infused after the cyclophosphamide course. The trial enrolls adults with high‑risk acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), or intermediate‑to‑very high‑risk myelodysplastic syndromes (MDS) who are eligible for allogeneic transplant. Key outcomes include progression‑free survival, engraftment kinetics, rates of acute and chronic GVHD, and transplant‑related mortality. This is a phase 2, single‑center protocol at Case Comprehensive Cancer Center testing safety and efficacy of the co‑transplant sequence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants with the following hematologic malignancies:

  * Acute myelogenous leukemia (AML): High-risk AML including:

    * Antecedent hematological disease (e.g., myelodysplasia (MDS))
    * Treatment-related
    * Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, TP53 mutations, complex cytogenetics)
    * Participants must be in CR1, CR2, CR3 or CRi
  * Acute lymphoblastic leukemia (ALL)

    * High-risk CR1 including:

      * Poor-risk cytogenetics (e.g., t(9;22)or 11q23 rearrangements)
      * Presence of minimal disease by flow cytometry or PCR or Clonoseq after 2 or more cycles of chemotherapy
      * No CR within 4 weeks of initial treatment
    * Participants in CR2 or beyond
    * Participants must be in CR1, CR2, CR3, or CRi
  * Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system (IPSS-R) or treatment related MDS
  * High-risk lymphoma
* Age \> 18 years
* Participants without a suitable HLA-matched related or unrelated donor CASE9Z24 Page 17 Version dated 12.16.2025
* Participants with the following suitable grafts:

  * A 4-8/8 HLA high resolution matched cord blood unit with a cell dose of 1.0x105 CD34 cells/kg.
  * A haplo-identical donor with a goal cell dose of \> 4.0x106 CD34cells/kg (minimum 2 x106 CD34 cells/kg)
* Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia including standard intrathecal chemotherapy and/or radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Participants must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.
* Participants must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Participants with inadequate Organ Function as defined by:

  * Creatinine clearance \< 40ml/min (Cockcroft-Gault)
  * Bilirubin \> 2X institutional upper limit of normal unless Gilbert syndrome
  * AST (SGOT) \> 3X institutional upper limit of normal
  * ALT (SGPT) \> 3X institutional upper limit of normal
  * Pulmonary function: DLCOc \< 60%
  * Cardiac: left ventricular ejection fraction \< 40%
  * ECOG \<2
* Participants with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
* Prior autologous stem cell transplant or CAR-T within the preceding 6 months or prior allogeneic transplant.

Where it's running

• Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Leland Metheny, MD — Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center
• Study coordinator: Leland Metheny, MD
• Email: Leland.Metheny@uhhospitals.org
• Phone: 216-844-0139

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.