Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD)

Part of paid clinical trials in New Hyde Park, New York.

Sponsor
Northwell Health
Study ID
NCT05289167
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    37.5 mg/kg IV over 1 hour on Day +3 and +4
  • Abatacept — DRUG
    Dose level 0: 10 mg/kg IV over 30-60 minutes on day +5 Dose level 1: 10mg/kg IV over 30-60 minutes on day +5 and +14 Dose level 2: 10mg/kg IV over 30-60 minutes on day +5, +14, and +28
  • Bortezomib — DRUG
    1.3 mg/m2 IV 6 hours after graft infusion completion and 72 hours thereafter.

Study Details

This is a phase I-II clinical trial. Adult subjects with hematological malignancies undergoing allogeneic HSCT from an HLA matched sibling or ≥7 out of 8 allele level HLA matched unrelated donor are eligible for the study if they meet the criteria defined in our standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Subjects will receive a standard of care conditioning regimen. Subjects will receive investigational PTCy, investigational bortezomib and investigational abatacept as GvHD prophylaxis.

Key Dates

Start date
Mar 13, 2022
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
74 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with hematological malignancies
    Participants undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will receive a combination of cyclophosphamide, known commercially as Cytoxan®, abatacept, known as Orecia® and bortezomib commercially known as Velcade®, to reduce the rate of graft-versus-host disease (GvHD). These medications will be given for GvHD prevention during the transplant process.

Primary Outcome Measure

Phase I:Incidence Dose limiting toxicity (DLT) [ Time Frame: Day+1 to Day +120 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell HealthNew Hyde ParkNew York10016
Kelli Cole
[email protected]
516-734-8973
Angie Fleury
[email protected]
516-734-8973
A. Samer Al-Homsi, MD, MBA (PRINCIPAL_INVESTIGATOR)

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By research site
Northwell Health· New Hyde Park, NY

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