A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Part of paid clinical trials in Lake Success, New York.

Sponsor
Northwell Health
Study ID
NCT06681922
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Graft Vs Host Disease

Eligibility Criteria

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

Interventions

  • Cyclophosphamide, Bortezomib, Abatacept — DRUG
    Drug given for prevention of Graft-versus-Host Disease (GvHD) following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Study Details

The study will be conducted in two phases. The phase I portion will employ a 3+3 dose-escalation design to define the maximum tolerated dose (MTD) of abatacept added to PTCy and bortezomib following HSCT. The phase II portion will consist of two single-arm, open-label, optimal 2-stage Simon design studies conducted in two separate strata for HLA-matched and HLA-mismatched donor transplants.

Key Dates

Start date
Sep 23, 2024
Status verified
Dec 2024
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Determine the MTD of abatacept in combination with PTCy and bortezomib Determine the MTD of abatacept in combination with PTCy and bortezomib Determine the MTD of abatacept in combination with PTCy and bortezomib [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg Cancer CenterLake SuccessNew York11042
Kelli Cole

Find similar trials in Lake Success, NY

By research site
Zuckerberg Cancer Center· Lake Success, NY

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