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

NCT06904482 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CASE9Z24
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival(PFS) at 6 months after transplant

  Kaplan-Meier method will be used to estimate the PFS

  6 months after transplant

Secondary Outcomes (45)

• Progression free survival at 1 year after transplant

  1 year after transplant

• Progression free survival at 2 years after transplant

  2 years after transplant

• Progression free survival at 3 years after transplant

  3 years after transplant

• Non-relapse mortality at 1 year after transplant

  1 year after transplant

• Non-relapse mortality at 2 years after transplant

  2 years after transplant

Study Arms (1)

Haplo-Identical / Cord Blood Transplant

EXPERIMENTAL

Biological: Haplo-Identical / Cord Blood Transplant

Interventions

Haplo-Identical / Cord Blood Transplant BIOLOGICAL

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.

Haplo-Identical / Cord Blood Transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases

Study Officials

• Leland Metheny, MD

  Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leland Metheny, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 1, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): February 24, 2027
• Study Completion (Estimated): February 25, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Compiled and analyzed participant data will be published upon study completion. Publisher may request Protocol and Statistical Analysis Plan.

Locations

US (1)