Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis (ABA3)
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ClinicalTrials.gov Identifier: NCT04380740 |
Recruitment Status :
Recruiting
First Posted : May 8, 2020
Last Update Posted : January 23, 2024
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Sponsor:
Boston Children's Hospital
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Leslie Kean, Boston Children's Hospital
Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | May 5, 2020 | ||||||||||||||
First Posted Date ICMJE | May 8, 2020 | ||||||||||||||
Last Update Posted Date | January 23, 2024 | ||||||||||||||
Actual Study Start Date ICMJE | March 30, 2022 | ||||||||||||||
Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS) [ Time Frame: 2 years ] SGRFS will be modeled as a time-to-event outcome, and as such, failures that occur beyond one year and before study end will be considered in the analysis.
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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 | Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis | ||||||||||||||
Official Title ICMJE | A Randomized Double-Blind Trial of Abatacept Extended Dosing Versus Abatacept Short-term Dosing for Graft Versus Host Disease Prophylaxis: "ABA3" | ||||||||||||||
Brief Summary | This is a multicenter randomized, double blind, Phase 2 trial for patients receiving transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis, will be compared for their ability to improve outcomes in patients with a minimum follow-up of one year post-transplant. All patients will receive 4 doses of abatacept (Days -1, +5, +14, +28). Prior to the fifth dose, patients will be randomly assigned to the 4-dose abatacept arm and receive 4 doses of placebo or 8-dose abatacept arm and receive 4 more doses of abatacept. The primary endpoint of the study will be severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS). The study will end when the last patient has reached 2 years after transplant. Results will first be calculated and the study unblinded when the last patient has reached one year post-transplant. | ||||||||||||||
Detailed Description | Not Provided | ||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Graft Vs Host Disease | ||||||||||||||
Intervention ICMJE |
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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 |
160 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | April 2025 | ||||||||||||||
Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 2 Years and older (Child, Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04380740 | ||||||||||||||
Other Study ID Numbers ICMJE | IRB-P00035528 20-227 ( Other Identifier: Dana-Farber Cancer Institute ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Leslie Kean, Boston Children's Hospital | ||||||||||||||
Original Responsible Party | Leslie Kean, Boston Children's Hospital, MD, PhD | ||||||||||||||
Current Study Sponsor ICMJE | Boston Children's Hospital | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Bristol-Myers Squibb | ||||||||||||||
Investigators ICMJE | Not Provided | ||||||||||||||
PRS Account | Boston Children's Hospital | ||||||||||||||
Verification Date | January 2024 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |