Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis

Part of paid clinical trials in Duarte, California.

Sponsor
Boston Children's Hospital
Study ID
NCT04380740
Phase
PHASE2
Status
Recruiting
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Conditions

  • Graft Vs Host Disease

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    During the extended dosing of abatacept, those randomized to receive 4 doses will receive a placebo consisting of an equal volume of normal saline solution.
  • Abatacept — DRUG
    Investigational prophylaxis with extended-dosing abatacept, a calcineurin inhibitor and methotrexate.

Study Details

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.

Key Dates

Start date
Mar 30, 2022
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Standard GVHD Prophylaxis + Abatacept + Placebo
    Standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate + 4 doses of Abatacept (investigational product) + 4 doses of Placebo.
  • Experimental: Standard GVHD Prophylaxis + Abatacept Extended dosing
    Standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate + 8 doses of Abatacept.

Primary Outcome Measure

Severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS) [ Time Frame: 2 years ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
City Of Hope National Medical CenterDuarteCalifornia91010-
Moffitt Cancer CenterTampaFlorida33612-
Children's Healthcare of AtlantaAtlantaGeorgia30329
Muna Qayed, MD
[email protected]
404-785-1112
Muna Qayed, MD (PRINCIPAL_INVESTIGATOR)
Emory University/Winship Cancer CenterAtlantaGeorgia30322-
University of ChicagoChicagoIllinois60637
James LaBelle, MD
James LaBelle, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Boston Children's HospitalBostonMassachusetts02115
Brandi Bratrude, BA
[email protected]
6179192197
Leslie S Kean, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Washington University St. LouisSt LouisMissouri63110-
University of RochesterRochesterNew York14642
Eric Huselton, MD
[email protected]
Eric Huselton, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's HospitalCincinnatiOhio45229-
Oregon Health and Sciences UniversityPortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

Find similar trials in Duarte, CA

By research site
City Of Hope National Medical Center· Duarte, CAMoffitt Cancer Center· Tampa, FLChildren's Healthcare of Atlanta· Atlanta, GAEmory University/Winship Cancer Center· Atlanta, GAUniversity of Chicago· Chicago, ILBeth Israel Deaconess Medical Center· Boston, MA

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