Condition or disease | Intervention/treatment | Phase |
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Acute Graft Versus Host Disease Haploidentical Hematopoietic Stem Cell Transplant | Drug: ApoGraft | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The first three recipients will be treated in a sequential manner meaning that subjects will be transplanted with ApoGraft only after the engraftment of the previous subject has occurred. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of ApoGraft for the Prevention of Acute Graft Versus Host Disease in Haploidentical Hematopoietic Cell Transplant Recipients |
Actual Study Start Date : | December 16, 2020 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |
Arm | Intervention/treatment |
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Experimental: Recipient
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Drug: ApoGraft
ApoGraft is a cell based product, manufactured with mobilized peripheral blood.
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No Intervention: Donor
-Donors will undergo apheresis from peripheral blood after daily G-CSF administration (for up to 5 days prior to Day -1)
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Recipient Inclusion Criteria:
Hematologic malignancy in remission or controlled as below:
Subjects must have adequate organ function as defined below within 2 weeks of Day 0:
Recipient Exclusion Criteria:
Donor Inclusion Criteria
Donor criteria according to standard NMDP criteria for donor selection.
Donor Exclusion Criteria
Contact: Zhifu Xiang, M.D. | 314-454-8304 | zxiang@wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Zhifu Xiang, M.D. 314-454-8304 zxiang@wustl.edu | |
Principal Investigator: Zhifu Xiang, M.D. | |
Sub-Investigator: Mark A Schroeder, M.D. | |
Sub-Investigator: John F DiPersio, M.D., Ph.D. | |
Sub-Investigator: Peter Westervelt, M.D., Ph.D. | |
Sub-Investigator: Camille Abboud, M.D. | |
Sub-Investigator: Amanda Cashen, M.D. | |
Sub-Investigator: Keith Stockerl-Goldstein, M.D. | |
Sub-Investigator: Ravi Vij, M.D. | |
Sub-Investigator: Geoffrey Uy, M.D. | |
Sub-Investigator: Mathew Walter, M.D. | |
Sub-Investigator: Todd Fehniger, M.D., Ph.D. | |
Sub-Investigator: Armin Ghobadi, M.D. | |
Sub-Investigator: Meagan Jacoby, M.D., Ph.D. | |
Sub-Investigator: Iskra Pusic, M.D. | |
Sub-Investigator: Lukas Wartman, M.D. | |
Sub-Investigator: John Welch, M.D., Ph.D. | |
Sub-Investigator: Francesa Ferraro, M.D. | |
Sub-Investigator: Matthew Christopher, M.D., Ph.D. |
Principal Investigator: | Zhifu Xiang, M.D. | Washington University School of Medicine |
Tracking Information | |||||||
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First Submitted Date ICMJE | July 1, 2019 | ||||||
First Posted Date ICMJE | July 5, 2019 | ||||||
Last Update Posted Date | December 21, 2020 | ||||||
Actual Study Start Date ICMJE | December 16, 2020 | ||||||
Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Safety and tolerability of ApoGraft as measured by adverse events related to ApoGraft product [ Time Frame: From day 0 to 1 year post-transplantation of ApoGraft product ] -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | ApoGraft for the Prevention of Acute Graft Versus Host Disease in Haploidentical Hematopoietic Cell Transplant Recipients | ||||||
Official Title ICMJE | A Phase I Study of ApoGraft for the Prevention of Acute Graft Versus Host Disease in Haploidentical Hematopoietic Cell Transplant Recipients | ||||||
Brief Summary | Finding a donor remains a challenge for patients in need of an urgent hematopoietic stem cell transplantation (HSCT). The ability to obtain half matched stem cells from any family member represents a significant breakthrough in the field. Haploidentical haplo-HSCT is characterized by the nearly uniform and immediate availability of a donor and the availability of the donor for post-transplant cellular immunotherapy. However, haplo-HSCT has a high risk of Graft versus Host Disease (GvHD) and poor immune reconstitution when GvHD is prevented by all existing methods of vigorous ex vivo or in vivo T-cell depletion. Different treatment approaches are currently being explored to mitigate complications such as graft rejection, severe GvHD, and prolonged immune suppression. Novel experimental utilization of T regulatory cells, alloreactive natural killer (NK) cells, and other T cell subsets hold great promise. Cellect Biotherapeutics' platform technology, ApoGraft, is based on the findings that GvHD can be prevented by Fas receptor mediated selective depletion of T cell subsets, ex vivo. The investigators hypothesize that the use of ApoGrafts for haplo-HSCT will be safe, and reduce rates of GVHD without affecting Graft-versus-Leukemia (GvL). | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: The first three recipients will be treated in a sequential manner meaning that subjects will be transplanted with ApoGraft only after the engraftment of the previous subject has occurred. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: ApoGraft
ApoGraft is a cell based product, manufactured with mobilized peripheral blood.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
36 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||
Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Recipient Inclusion Criteria:
Recipient Exclusion Criteria:
Donor Inclusion Criteria
Donor Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04006652 | ||||||
Other Study ID Numbers ICMJE | 201911131 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Washington University School of Medicine | ||||||
Study Sponsor ICMJE | Washington University School of Medicine | ||||||
Collaborators ICMJE | Cellect Biotechnology | ||||||
Investigators ICMJE |
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PRS Account | Washington University School of Medicine | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |