Recruiting
Phase 2

Observational Study

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06904482

Conditions

aGVHD

Acute Myelogenous Leukemia

Acute Lymphocytic Leukemia

Myelodysplastic Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Haplo-Identical / Cord Blood Transplant

Study Details

Brief summary:

The purpose of this study is to see if see if adding the specific combination of donors can result in acceptable levels of survival without evidence of disease.

Conditions

aGVHD

Acute Myelogenous Leukemia

Acute Lymphocytic Leukemia

Myelodysplastic Syndromes

Study ID

NCT06904482

Start date

Aug 13, 2025

Status verified date

Feb, 2026

Completion date

Feb 25, 2030

Anticipated

Primary completion date

Feb 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Haplo-Identical / Cord Blood Transplant

Interventions

Haplo-Identical / Cord Blood Transplant

Cord Blood Unit Selection Cord Blood Unit Selection should be consistent with published guidelines5 with the understanding that the goal cell dose is 1x105 CD34 cells/kg in this protocol. ABO matching and donor specific antibodies should be taken into account in the selection of the CB unit.

Haplo-Donor Selection Haplo-identical siblings and younger male donors are preferred. ABO matching, CMV compatibility, and donor specific antibodies should be taken into account in the selection of the donor.

Primary outcome measure

  • Progression free survival(PFS) at 6 months after transplant [ Time Frame: 6 months after transplant ]

Central Contacts and Locations

Central contacts

Leland Metheny, MD

216-844-0139Leland.Metheny@uhhospitals.org

Locations

Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Unmodified Haplo-Identical Graft with Cord Blood
  • post-transplant cyclophosphamide aGVHD prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-02-27.