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

Launched by CASE COMPREHENSIVE CANCER CENTER · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to find out if combining two types of stem cell donors—one from a family member and one from umbilical cord blood—can help people with certain blood cancers live longer without the disease coming back. The trial will focus on patients with conditions like acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndromes (MDS) who do not have a matching donor.

To be eligible, participants must be over 18 years old, have specific high-risk types of these blood cancers, and need to have certain types of stem cells available for the transplant. During the study, participants will receive treatment and regular check-ups to monitor their health and response to the therapy. It’s important to note that this trial is not yet recruiting patients, so those interested will need to wait for it to start. Additionally, women who are pregnant or breastfeeding cannot participate due to potential risks from the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 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.
• • 2. Age \> 18 years
• • 3. Participants without a suitable HLA-matched related or unrelated donor
• 4. 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)
• • 5. 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.
• • 6. Participants must have the ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria:
• 1. 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
• • 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.
• • 3. Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.
• • 4. 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.
• • 5. Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
• • 6. Prior autologous stem cell transplant or CAR-T within the preceding 6 months or prior allogeneic transplant.