Actively Recruiting
A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Led by Northwell Health · Updated on 2026-05-29
74
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the prevention of graft-versus-host disease (GvHD) in adults with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It is a phase I-II clinical trial that includes patients receiving stem cells from either an HLA matched sibling or a closely matched unrelated donor. The study seeks to define the highest safe dose of abatacept combined with post-transplant cyclophosphamide and bortezomib and to assess this combination's effect on reducing GvHD. Participants will receive a standard conditioning treatment before transplant, followed by peripheral blood stem cell infusion. Those with unrelated donors will also get rabbit anti-thymocyte globulin. The trial has a phase I dose-escalation part to find the maximum tolerated dose of abatacept and a phase II part with two groups based on donor type. All subjects will receive investigational post-transplant cyclophosphamide, bortezomib, and abatacept to prevent GvHD. During the study, participants will be closely monitored for side effects and incidence of acute and chronic GvHD, graft failure, survival rates, and relapse over periods ranging from one month up to two years. Safety and effectiveness data will be collected through regular clinical assessments and laboratory tests. Participants will be followed for up to 730 days to evaluate outcomes such as treatment-related mortality and overall survival.
CONDITIONS
Brief Title
Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older
- Karnofsky performance score of 70% or higher
- No evidence of progressive bacterial, viral, or fungal infection
- Creatinine clearance greater than 50 mL/min/1.72m2
- ALT and AST liver enzymes less than 3 times the upper normal limit
- Total bilirubin less than 2 times the upper normal limit (except Gilbert's syndrome)
- Alkaline phosphatase 250 IU/L or less
- Left ventricular ejection fraction greater than 45%
- Adjusted carbon monoxide diffusing capacity greater than 50%
- Negative HIV test
- Negative pregnancy test confirmed by serum beta-hCG
- Willingness to comply with all study procedures and availability for study duration
You will not qualify if you...
- Pregnant or nursing women or women of reproductive capability unwilling to use effective contraception
- Male subjects unwilling to use effective barrier contraception or abstain from heterosexual intercourse during study and 90 days after last dose
- Inability to provide informed consent
- Recent myocardial infarction within 6 months or severe heart conditions including NYHA Class III or IV heart failure
- Known allergies to any study treatment components
- Serious medical or psychiatric illness likely to interfere with participation
- Diagnosis or treatment of another cancer within 3 years except certain low-risk skin or prostate cancers
- Participation in other clinical trials with investigational agents within 14 days before and during this trial
- Prisoners
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 28 days following transplant
Participants receive a combination of cyclophosphamide, bortezomib, and abatacept as graft-versus-host disease (GvHD) prophylaxis following allogeneic hematopoietic stem cell transplantation (HSCT). Treatments occur on specific days after transplant as part of the protocol to prevent GvHD.
Multiple visits for drug administration on Days +1, +3, +4, +5, +14, and +28 depending on dose level
Duration - Up to 2 years after treatment
Participants are monitored for acute and chronic graft-versus-host disease, graft function, treatment-related mortality, relapse, and overall survival following treatment.
Regular follow-up visits up to 2 years post-transplant
Trial Site Locations
Total: 1 location
1
Northwell Health
New Hyde Park, New York, United States, 10016
Actively Recruiting
Research Team
K
Kelli Cole
A
Angie Fleury
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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