Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood for Blood Cancers

This study is investigating a new approach to stem cell transplantation for people with high-risk blood cancers like acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and myelodysplastic syndromes (MDS). It combines two types of donor cells: a haplo-identical graft (from a partially matched family member) and cord blood. The goal is to see if this combination, along with a medication called post-transplant cyclophosphamide to prevent graft-versus-host disease (aGVHD), can lead to acceptable survival rates without the cancer returning. This approach aims to make transplants more available, especially for Black, Asian, and Hispanic populations who often have a harder time finding fully matched donors. The study plans to enroll 36 participants, and the current recruitment status is unclear.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 36 participants, but the phase of the study is not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary goal is to measure progression-free survival (PFS), which means living without the cancer returning, at 6 months after the transplant.

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Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood

Recruiting

PHASE2Ages 18+InterventionalTreatment

Case Comprehensive Cancer Center

~36 participants

Updated 2026-02-27 on ClinicalTrials.gov

What's tested:Haplo-Identical / Cord Blood Transplant

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Progression free survival(PFS) at 6 months after transplant

Measured over 6 months after transplant

Conditions

aGVHD

Acute Myelogenous Leukemia

Acute Lymphocytic Leukemia

Myelodysplastic Syndromes

Where it's being run

1 sites across 1 states

Ohio1

Study leadership

Leland Metheny, MD · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center

Who to contact

Leland Metheny, MD

[email protected]

216-844-0139

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Progression free survival(PFS) at 6 months after transplant6 months after transplant
Kaplan-Meier method will be used to estimate the PFS

Trialytics