Actively Recruiting
Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood for Patients with Hematologic Malignancies
Led by Case Comprehensive Cancer Center · Updated on 2026-02-27
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new transplant method for patients with certain blood cancers who do not have a matching donor. This study evaluates whether combining two types of donor cells—haplo-identical grafts and cord blood—can improve survival without evidence of disease. This approach aims to increase donor availability, especially for Black, Asian, and Hispanic populations who have lower chances of finding matched donors. The study uses post-transplant cyclophosphamide to reduce complications after transplant. The treatment involves giving patients an unmodified haplo-identical graft first, followed by an infusion of cord blood after completing cyclophosphamide therapy. Cord blood and haplo-identical donors are carefully selected based on compatibility factors including cell counts and antibodies. The goal is to deliver enough donor cells to support recovery and reduce disease relapse. This is a Phase 2 study focusing on patients with high-risk acute myelogenous leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or lymphoma. Participants will be closely monitored for at least six months after transplant to measure progression-free survival, which is the main outcome. Additional follow-up will continue for up to three years to assess survival, graft-versus-host disease, relapse rates, infections, and recovery of blood cells. Researchers will gather laboratory tests, clinical assessments, and detailed safety information to evaluate the treatment's effects. The study aims to improve transplant options and outcomes for patients lacking matched donors.
CONDITIONS
Brief Title
Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with high-risk acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS), or high-risk lymphoma
- AML patients must be in complete remission stages CR1, CR2, CR3, or CRi with specific risk factors
- ALL patients must be in CR1, CR2, CR3, or CRi with defined high-risk features
- MDS patients with intermediate, high, or very high risk by IPSS-R or treatment-related MDS
- No suitable human leukocyte antigen (HLA)-matched related or unrelated donor available
- Suitable grafts available: 4-8/8 HLA matched cord blood unit with required cell dose and haplo-identical donor with minimum cell dose
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Inadequate organ function: creatinine clearance less than 40 ml/min, bilirubin over 2 times normal (unless Gilbert syndrome), liver enzymes (AST/ALT) over 3 times normal
- Lung function (DLCOc) less than 60%
- Heart function (left ventricular ejection fraction) less than 40%
- ECOG performance status less than 2
- Uncontrolled or active infections, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting participation
- Pregnant or breastfeeding women
- Known allergies or intolerance to study medications or similar compounds
- Prior autologous stem cell transplant or CAR-T therapy within 6 months
- Any condition that interferes with safe study participation or data interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 days post treatment
Participants receive a co-transplant of an unmodified haplo-identical graft followed by cord blood infusion after post-transplant cyclophosphamide as part of the transplantation process for hematologic malignancies.
Multiple visits for transplantation and monitoring during active treatment period
Duration - Up to 3 years after transplant
Participants are monitored for safety, graft versus host disease, infections, and progression free survival for up to 3 years after transplant.
Regular visits for assessments up to 3 years
Trial Site Locations
Total: 1 location
1
Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
L
Leland Metheny, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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