deltatrials
Terminated PHASE2 INTERVENTIONAL 1-arm NCT00968864

T-cell Depleted Alternative Donor Transplantation

A Phase II Study Using the CliniMACS® Device for CD34+ Cell Selection and T Cell Depletion for Graft-versus-Host Disease Prophylaxis in Alternative Donor Stem Cell Transplant Recipients

Sponsor: Wake Forest University Health Sciences

Updated 9 times since 2017 Last updated: Apr 20, 2022 Started: Aug 31, 2009 Primary completion: Nov 30, 2016 Completion: Nov 30, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Sponsor/ PI leaving institution, no plans to continue this research at this time

Listed as NCT00968864, this PHASE2 trial focuses on Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia and remains terminated or withdrawn. Sponsored by Wake Forest University Health Sciences, it has been updated 9 times since 2009, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

A major issue in alternative donor (mismatched related and unrelated donor transplantation is the development of graft-versus-host disease (GVHD). Several clinical trials have shown that the use of T-cell depleted peripheral blood stem cells (PBSC) reduces GVHD in alternative donor transplants. The purpose of this study is to determine the ability of CD34 positive selection and T cell depletion using the CliniMACS® Device as the only GVHD prophylaxis to prevent severe acute GVHD in recipients of an alternative donor PBSC transplant. Mismatched related donors will match at least 3 of 6 Human leukocyte antigens(HLA)(haplocompatible) and unrelated donors will match at least 6 out of 8 HLA antigens with the transplant recipient. The conditioning therapy including chemotherapy, anti-thymocyte globulin (ATG), +/- total body irradiation (TBI) will be based on the patient's diagnosis. The transplant recipient will be followed for 5 years after transplant for GVHD, engraftment, post-transplant infections, disease relapse, and overall survival. In addition, this study will serve as a platform for a companion study of therapy to accelerate immune recovery after transplant.

A major issue in alternative donor (mismatched related and unrelated donor transplantation is the development of graft-versus-host disease (GVHD). Several clinical trials have shown that the use of T-cell depleted peripheral blood stem cells (PBSC) reduces GVHD in alternative donor transplants. The purpose of this study is to determine the ability of CD34 positive selection and T cell depletion using the CliniMACS® Device as the only GVHD prophylaxis to prevent severe acute GVHD in recipients of an alternative donor PBSC transplant. Mismatched related donors will match at least 3 of 6 Human leukocyte antigens(HLA)(haplocompatible) and unrelated donors will match at least 6 out of 8 HLA antigens with the transplant recipient. The conditioning therapy including chemotherapy, anti-thymocyte globulin (ATG), +/- total body irradiation (TBI) will be based on the patient's diagnosis. The transplant recipient will be followed for 5 years after transplant for GVHD, engraftment, post-transplant infections, disease relapse, and overall survival. In addition, this study will serve as a platform for a companion study of therapy to accelerate immune recovery after transplant.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Dec 2017 · 10 months · monthly snapshotTerminated~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotTerminated~Jun 2018 – ~May 2019 · 11 months · monthly snapshotTerminated~May 2019 – ~Jan 2021 · 20 months · monthly snapshotTerminated~Jan 2021 – ~May 2022 · 16 months · monthly snapshotTerminated~May 2022 – ~Jul 2024 · 26 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated

Change History

9 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. May 2022 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jan 2021 — May 2022 [monthly]

    Terminated PHASE2

  5. May 2019 — Jan 2021 [monthly]

    Terminated PHASE2

Show 4 earlier versions
  1. Jun 2018 — May 2019 [monthly]

    Terminated PHASE2

  2. Dec 2017 — Jun 2018 [monthly]

    Terminated PHASE2

  3. Feb 2017 — Dec 2017 [monthly]

    Terminated PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE2

    First recorded

Aug 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Wake Forest University Health Sciences
Data source: Wake Forest University Health Sciences

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

Study Locations