Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft (NCT05088356)
Phase 1 Trial for Patients With Advanced Hematologic Malignancies Undergoing Reduced Intensity Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Stanford University โ Stanford, California
Age range: 18 Years to 75 Years
๐งช Interventions in This Study
- Purified regulatory T-cells (Treg) plus CD34+ HSPC (DRUG)
- Fludarabine (DRUG)
- Melphalan (DRUG)
- CliniMACS CD34 Reagent System (DEVICE)
- Tacrolimus (DRUG)
- Cyclophosphamide (DRUG)
- Plerixafor (DRUG)
- Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent (DRUG)
- Thiotepa (DRUG)
- Mycophenolate Mofetil (MMF) (DRUG)
- Ruxolitinib (DRUG)
- Sirolimus (DRUG)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Stanford University โ Stanford, California
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Allogeneic Hematopoietic Cell Transplantation (HCT) clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.