NCT05088356 Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
| NCT ID | NCT05088356 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Stanford University |
| Condition | Allogeneic Hematopoietic Cell Transplantation (HCT) |
| Study Type | INTERVENTIONAL |
| Enrollment | 77 participants |
| Start Date | 2021-09-07 |
| Primary Completion | 2027-11 |
Trial Parameters
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Brief Summary
Reduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for myeloablative conditioning. In this study, we aim to use RIC followed by matched related/unrelated donor, 7/8 matched related/unrelated donor, or haploidentical donor peripheral blood stem cell transplantation. Standard strategies to control the alloreactivity following HCT utilize immunosuppressive or cytotoxic medications. In this study, we explore donor graft engineering to enrich for immmunoregulatory populations to facilitate post transplantation immune reconstitution while minimizing graft versus host disease (GVHD) with post-transplant immunosuppressive agents.
Eligibility Criteria
Inclusion Criteria: Recipient Inclusion Criteria a. Patients with the following diseases that are histopathologically-confirmed are eligible * Acute myeloid, lymphoid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) or beyond first complete remission (CR1) without the presence of minimal residual disease * Acute myeloid, leukemia, or mixed phenotype leukemia that is either: * Not in morphologic CR with bone marrow infiltration by leukemic blasts of ≤10%, or * In morphologic CR with evidence of minimal residual disease positivity by either multiparametric flow cytometric analysis or by a nucleic acid-based technique * Primary refractory acute myeloid, lymphoid, or mixed phenotype leukemia * Chronic myelogenous leukemia (accelerated, blast or second chronic phase) * Myelodysplastic syndromes * Myeloproliferative syndromes b. Match to the patient as follows: 1. For Arm A1 (CLOSED): * Availability of a 8/8 or 7/8 HLA-matched donor (re