Status:
RECRUITING
Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
aGVHD
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
Cord blood (CB) and haplo-identical grafts are valuable alternative graft sources for patients with hematologic malignancies in need of allogeneic transplantation who lack human leukocyte antigen (HLA...
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)
- Participant 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 Participant 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.
- Age \> 18 years
- Participants without a suitable HLA-matched related or unrelated donor
- Participant with the following suitable grafts:
- A 4-8/8 HLA high resolution matched CB 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/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 subject; 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.
Key Trial Info
Start Date :
August 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 25 2030
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06904482
Start Date
August 13 2025
End Date
February 25 2030
Last Update
August 17 2025
Active Locations (1)
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1
Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center
Cleveland, Ohio, United States, 44106