RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 sites (1)

OH

  • Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center · Cleveland, OH 44106Leland Metheny, MD · Study contactMore trials in Cleveland