aGVHDPhase 2NCT06904482
Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood
A Phase 2 study testing Haplo-Identical / Cord Blood Transplant in people with aGVHD and Acute Myelogenous Leukemia, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- aGVHD, Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia
- What is being tested?
- Haplo-Identical / Cord Blood Transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2025to 25 Feb 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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%
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center
Cleveland, Ohio, 44106
Leland Metheny, MD
About this study
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.
Read the 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)-matched adult donors. In Black, Asian, Hispanic populations, the chance of finding a HLA matched donor is 23%, 41%, and 46%, respectively. These graft sources allow for greater HLA difference between donor and recipient, and increase the availability of donors, and therefore transplant, to these populations. Comparative retrospective analyses demonstrate similar results when compared to haplo/cord transplants. In this variant of the standard haplo/cord transplant, investigators will utilize post-transplant cyclophosphamide aGVHD prophylaxis after infusion of the haplo-identical graft and then infuse the CB graft after completion of post-transplant cyclophosphamide. Our hypothesis is that the combination of these two graft sources in which the haplo-identical graft is unmanipulated and the CB graft is infused after post-transplant cyclophosphamide, will be safe and result in effective disease eradication as measured by progression free survival in high risk patients.
- Being tested
- Haplo-Identical / Cord Blood Transplant
- Keywords
- Unmodified Haplo-Identical Graft with Cord Blood, post-transplant cyclophosphamide aGVHD prophylaxis
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haplo-Identical / Cord Blood TransplantBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Haplo-Identical / Cord Blood Transplant | Experimental | Not described Receives: Biological: Haplo-Identical / Cord Blood Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival(PFS) at 6 months after transplant
Kaplan-Meier method will be used to estimate the PFS
Measured: 6 months after transplant
Secondary outcomes (45)
Progression free survival at 1 year after transplant
Kaplan-Meier method will be used to estimate the PFS
Measured: 1 year after transplant
Progression free survival at 2 years after transplant
Kaplan-Meier method will be used to estimate the PFS
Measured: 2 years after transplant
Progression free survival at 3 years after transplant
Kaplan-Meier method will be used to estimate the PFS
Measured: 3 years after transplant
Non-relapse mortality at 1 year after transplant
Measured: 1 year after transplant
Non-relapse mortality at 2 years after transplant
Measured: 2 years after transplant
Non-relapse mortality at 3 years after transplant
Measured: 3 years after transplant
Overall survival(OS) at 1 year after transplant
Kaplan-Meier method will be used to estimate the OS
Measured: 1 year after transplant
Overall survival at 2 years after transplant
Kaplan-Meier method will be used to estimate the OS
Measured: 2 years after transplant
Overall survival at 3 years after transplant
Kaplan-Meier method will be used to estimate the OS
Measured: 3 years after transplant
Graft versus host disease relapse free survival at 1 year after transplant
Measured: 1 year after transplant
Graft versus host disease relapse free survival at 2 years after transplant
Measured: 2 years after transplant
Graft versus host disease relapse free survival at 3 years after transplant
Measured: 3 years after transplant
Relapse at 1 year after transplant.
Measured: 1 year after transplant.
Relapse at 2 years after transplant.
Measured: 2 years after transplant.
Relapse at 3 years after transplant.
Measured: 3 years after transplant.
Rate of grade III-IV Acute Graft Versus Host Disease (aGVHD) at 30 days after transplant
Measured: 30 days after transplant
Rate of grade III-IV aGVHD at 100 days after transplant
Measured: 100 days after transplant
Rate of grade III-IV aGVHD at 6 months after transplant
Measured: 6 months after transplant
Rate of grade III-IV aGVHD at 1 year after transplant
Measured: 1 year after transplant
Rate of grade III-IV aGVHD at 2 years after transplant
Measured: 2 years after transplant
Rate of grade III-IV aGVHD at 3 years after transplant
Measured: 3 years after transplant
Rate of grade II-IV aGVHD at 30 days after transplant
Measured: 30 days after transplant
Rate of grade II-IV aGVHD at 100 days after transplant
Measured: 100 days after transplant
Rate of grade II-IV aGVHD at 6 months after transplant
Measured: 6 months after transplant
Rate of grade II-IV aGVHD at 1 year after transplant
Measured: 1 year after transplant
Rate of grade II-IV aGVHD at 2 years after transplant
Measured: 2 years after transplant
Rate of grade II-IV aGVHD at 3 years after transplant
Measured: 3 years after transplant
Rate of severe Chronic Graft Versus Host Disease (cGVHD) at 100 days after transplant.
Measured: 100 days after transplant
Rate of severe cGVHD at 6 months after transplant.
Measured: 6 months after transplant
Rate of severe cGVHD at 1 year after transplant.
Measured: 1 year after transplant
Rate of severe cGVHD at 2 years after transplant.
Measured: 2 years after transplant
Rate of severe cGVHD at 3 years after transplant.
Measured: 3 years after transplant
Rate of moderate cGVHD at 100 days after transplant
Measured: 100 days after transplant
Rate of moderate cGVHD at 6 months after transplant
Measured: 6 months after transplant
Rate of moderate cGVHD at 1 year after transplant
Measured: 1 year after transplant
Rate of moderate cGVHD at 2 years after transplant
Measured: 2 years after transplant
Rate of moderate cGVHD at 3 years after transplant
Measured: 3 years after transplant
Rate of mild cGVHD at 100 days after transplant
Measured: 100 days after transplant
Rate of mild cGVHD at 6 months after transplant
Measured: 6 months after transplant
Rate of mild cGVHD at 1 year after transplant
Measured: 1 year after transplant
Rate of mild cGVHD at 2 years after transplant
Measured: 2 years after transplant
Rate of mild cGVHD at 3 years after transplant
Measured: 3 years after transplant
Rate of serious infections at 1 year after transplant
Measured: 1 year after transplant
Time to neutrophil engraftment.
Neutrophil engraftment will be calculated as the days from transplant where the absolute neutrophil count (ANC) reaches >500cells/ul x 3 days.
Measured: 60 days post treatment
Time to platelet engraftment.
Platelet engraftment will be calculated as the days from transplant where the platelet count reaches 20,000 platelets /ul without the need of transfusion of platelets for 7 days.
Measured: 60 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start13 Aug 2025
- Primary completion24 Feb 2027 (estimated)
- Study completion25 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for aGVHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leland Metheny, MD, Principal investigator, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904482
- Sponsor's protocol ID
- CASE9Z24
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in publication