deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 9-arm NCT01660607

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)

Updated 16 times since 2017 Last updated: Aug 18, 2025 Started: Feb 9, 2012 Primary completion: Dec 20, 2023 Completion: Dec 20, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~May 2019 · 10 months · monthly snapshot~May 2019 – ~Jul 2019 · 2 months · monthly snapshot~Jul 2019 – ~Sep 2020 · 14 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jun 2022 · 9 months · monthly snapshot~Jun 2022 – ~Dec 2023 · 18 months · monthly snapshot~Dec 2023 – ~Mar 2024 · 3 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshot~Sep 2025 – present · 7 months · monthly snapshot

Change History

16 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Feb 2025 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Sep 2024 — Feb 2025 [monthly]

    Completed PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  5. Mar 2024 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not RecruitingCompleted

Show 11 earlier versions
  1. Dec 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Jun 2022 — Dec 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: RecruitingActive Not Recruiting

  3. Sep 2021 — Jun 2022 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  5. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  6. Jul 2019 — Sep 2020 [monthly]

    Recruiting PHASE1_PHASE2

  7. May 2019 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

    Status: SuspendedRecruiting

  8. Jul 2018 — May 2019 [monthly]

    Suspended PHASE1_PHASE2

    Status: RecruitingSuspended

  9. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1_PHASE2

  10. Feb 2017 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  11. 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

Sponsor contact:
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)
  • Stanford University
Data source: Stanford University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations