A Phase 1 Trial of a Single ProHema® CB Product for Pediatric Patients With Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT02354417|
Recruitment Status : Terminated
First Posted : February 3, 2015
Results First Posted : October 10, 2018
Last Update Posted : October 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Biological: Biological: ProHema-CB||Phase 1|
A maximum of 18 eligible male and female subjects (1 to 18 years old, inclusive) will be enrolled and treated in the trial at approximately 3 to 5 centers within the U.S. These 18 subjects will consist of 3 cohorts of 6 subjects each. The cohorts will be defined by age: 1 to 4 years; > 4 to 12 years; and > 12 to 18 years. These cohorts will be enrolled simultaneously.
All subjects will be admitted to the hospital, per institutional practice, and will receive a myeloablative conditioning regimen, after which they will receive an HLA-matched or partially matched ProHema-CB unit on study Day 0.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Trial of a Single ProHema® CB Product (Ex Vivo Modulated Human Cord Blood Cells) Following Myeloablative Conditioning for Pediatric Patients With Hematologic Malignancies|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||February 2017|
All subjects will receive treatment with ProHema-CB (ex-vivo modulated human cord blood cells) transplant.
ProHema-CB (the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 also referred to as FT1050) will be prepared and administered in one of two formulations, based upon subject weight:
For subjects > 35 kg, ProHema-CB will be administered as 150 mL product in a blood bag via gravity infusion. It will be infused at 10 mL to 15 mL per minute, for a total infusion time of 10 to 15 min.
For subject's ≤ 35 kg, ProHema-CB will be administered as a 50 mL product in a syringe via syringe pump.o It will be infused at 5 mL/kg per hour for a total infusion time of up to ~1 hour.
Biological: Biological: ProHema-CB
Each subject will receive one administration of ProHema-CB unit transplant.
- Safety Profile, Primarily Assessed by Neutrophil Engraftment [ Time Frame: Neutrophil engraftment by Day 42 ]To describe the safety profile of ProHema-CB after myeloablative conditioning in pediatric patients with hematologic malignancies. The safety profile will primarily be assessed by neutrophil engraftment.
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): NCT02354417
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115-5450|
|Study Director:||Chris Storgard, MD||Fate Therapeutics|