Ex-vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-Versus-Host Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01795573|
Recruitment Status : Recruiting
First Posted : February 20, 2013
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Biological: Cultured Treg cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Ex-vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-Versus-Host Disease|
|Actual Study Start Date :||June 24, 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Cultured Treg cells
Co-culturing of recipient dendritic cells and donor Treg cells given prior to allogeneic stem cell transplant
Biological: Cultured Treg cells
Co-culturing of recipient dendritic cells and donor Treg. Treg administration will occur 2 days before the allogeneic stem cell transplant (i.e. day -2 with reference of day 0 as stem cell infusion date).
- Maximally Tolerated dose (MTD) [ Time Frame: Up to 1 year ]MTD of donor Treg in combination with standard dose SIR/TAC immune suppression. The occurrence of dose-limiting toxicity in >= 33% serves as the boundary for the MTD of donor Treg.
- Acute GVHD incidence [ Time Frame: Up to day 100 ]Clinical evidence of acute GVHD will be recorded per standard grading scheme. GVHD grade will be reported weekly from day 0-100 both for site-specific involvement, as well as an overall composite score.
- Relapse Free Survival [ Time Frame: Up to 1 year ]Defined as time from transplantation (day 0 as day of stem cell infusion per standard nomenclature) to relapse or death from any cause.
- Non-relapse Mortality [ Time Frame: Up to 1 year ]Defined as mortality while underlying malignancy is in remission.
- Overall Survival (OS) [ Time Frame: Up to 1 year ]Defined as time from transplantation (day 0 as day of stem cell infusion per standard nomenclature) to death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795573
|Contact: Joseph Pidala, MD, PhDfirstname.lastname@example.org|
|United States, Florida|
|H Lee Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Joseph Pidala, MD, PhD 813-745-2556 email@example.com|
|Contact: Michelle Burton 813-745-1537 firstname.lastname@example.org|
|Sub-Investigator: Melissa Alsina, MD|
|Sub-Investigator: Ernesto Ayala, MD|
|Sub-Investigator: Lia Perez, MD|
|Sub-Investigator: Jose Leonel Ochoa-Bayona, MD|
|Sub-Investigator: Brian Betts, MD|
|Sub-Investigator: Fred Locke, MD|
|Sub-Investigator: Farhad Khimani, MD|
|Sub-Investigator: Taiga Nishihori, MD|
|Sub-Investigator: Mohamed Kharfan-Dabaja, MD|
|Sub-Investigator: Asmita Mishra, MD|
|Sub-Investigator: Linda Kelley, PhD|
|Principal Investigator: Joseph Pidala, MD|
|Principal Investigator: Claudio Anasetti, MD|
|Sub-Investigator: Michael Nieder, MD|
|Principal Investigator:||Joseph Pidala, MD, PhD||Moffitt Cancer Center|