Trials / Completed
CompletedNCT01660607
Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell
Phase 1-2 Trial for Patients With Advanced Hematologic Malignancies Undergoing Myeloablative Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 13 Years – 73 Years
- Healthy volunteers
- Not accepted
Summary
This study looks at giving specific types of immune cells, called regulatory T cells and conventional T cells, to patients with blood cancers who are receiving a stem cell transplant. These cells are added back to help the immune system recover and reduce complications after the transplant.
Detailed description
Primary Objectives: * To determine the efficacy, safety and feasibility of administration of several dose combinations of conventional T cells (Tcon) and regulatory T cells (Treg) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) with HLA matched donors (related or unrelated) using a T cell depleted graft \[CD34+ hematopoietic progenitor cells ("CD34+ HSPC")\], without immune suppression. * To determine if concomitant single-agent immunosuppression is needed with fresh Treg cells (phase 2 stage 1) \* To determine 1-year GvHD-free relapse-free survival (GRFS) post-HCT (phase 2 stage 2). Secondary Objectives: * To determine the 1 year OS in patients undergoing allogeneic HCT with matched donors. * To measure the incidence and severity of acute and chronic graft vs host disease (GvHD) * To measure incidence of serious infections
Conditions
- Myeloid Leukemia, Chronic
- Acute Myelogenous Leukemia
- Myelodysplastic Syndromes (MDS)
- Lymphoma, Non-Hodgkin
- Acute Lymphoblastic Leukemia (ALL)
- Myeloproliferative Syndrome
- Acute Myeloid Leukemia
- Acute Leukemia
- Chronic Myelogenous Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD34+ Hematopoietic Progenitor Cells (HSPC) | Purified CD34+ hematopoietic progenitor cells used in transplantation. |
| BIOLOGICAL | Regulatory T-Cells (Treg) | Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease. |
| BIOLOGICAL | Conventional T-Cells (Tcon) | Conventional CD3+ T cells used for immune reconstitution and graft enhancement. |
| PROCEDURE | Myeloablative Conditioning Regimen | Chemotherapy or total body irradiation used before hematopoietic cell transplantation. |
Timeline
- Start date
- 2012-02-09
- Primary completion
- 2023-12-20
- Completion
- 2023-12-20
- First posted
- 2012-08-08
- Last updated
- 2025-08-19
- Results posted
- 2025-08-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01660607. Inclusion in this directory is not an endorsement.