NCT06904482 · Case Comprehensive Cancer Center
Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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%
- 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.
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations