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
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Listed as NCT01660607, this PHASE1/PHASE2 trial focuses on Acute Leukemia and Acute Lymphoblastic Leukemia (ALL) and remains completed. Sponsored by National Heart, Lung, and Blood Institute (NHLBI), it has been updated 16 times since 2012, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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
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
Status Flow
Change History
16 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE1/PHASE2
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Feb 2025 — Sep 2025 [monthly]
Completed PHASE1/PHASE2
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Sep 2024 — Feb 2025 [monthly]
Completed PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Mar 2024 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
Status: Active Not Recruiting → Completed
▶ Show 11 earlier versions
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Dec 2023 — Mar 2024 [monthly]
Active Not Recruiting PHASE1_PHASE2
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Jun 2022 — Dec 2023 [monthly]
Active Not Recruiting PHASE1_PHASE2
Status: Recruiting → Active Not Recruiting
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Sep 2021 — Jun 2022 [monthly]
Recruiting PHASE1_PHASE2
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Jan 2021 — Sep 2021 [monthly]
Recruiting PHASE1_PHASE2
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Sep 2020 — Jan 2021 [monthly]
Recruiting PHASE1_PHASE2
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Jul 2019 — Sep 2020 [monthly]
Recruiting PHASE1_PHASE2
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May 2019 — Jul 2019 [monthly]
Recruiting PHASE1_PHASE2
Status: Suspended → Recruiting
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Jul 2018 — May 2019 [monthly]
Suspended PHASE1_PHASE2
Status: Recruiting → Suspended
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Jun 2018 — Jul 2018 [monthly]
Recruiting PHASE1_PHASE2
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Feb 2017 — Jun 2018 [monthly]
Recruiting PHASE1_PHASE2
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE1_PHASE2
First recorded
Feb 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health (NIH)
- Stanford University
For direct contact, visit the study record on ClinicalTrials.gov .