Actively Recruiting
A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept to Prevent Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Led by Northwell Health · Updated on 2024-12-16
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of abatacept combined with post-transplant cyclophosphamide (PTCy) and bortezomib to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT) in adults with blood cancers. The study is conducted in two phases: a phase I dose-escalation to find the maximum tolerated dose of abatacept and a phase II evaluation in two groups based on donor matching. Participants must meet institutional criteria and have matched or partially matched donors. Participants receive a standard conditioning regimen followed by peripheral blood stem cell transplants. Those with unrelated donors also get rabbit anti-thymocyte globulin (rATG). The study drugs—PTCy, bortezomib, and abatacept—are given as GVHD prevention. The phase II dose of abatacept is determined from phase I results. Participants are grouped by donor type: matched sibling, matched unrelated, or mismatched unrelated donors. Throughout the study, participants are monitored for safety and treatment effects, including determining the maximum tolerated dose of abatacept over up to two years. They undergo regular assessments per standard care protocols and study procedures. The study is open-label and non-randomized, with no placebo group. Participants must be available for the full duration and comply with all study procedures.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Karnofsky performance score 70% or higher
- No active bacterial, viral, or fungal infections
- Creatinine clearance greater than 50 mL/min/1.72m2
- ALT and AST less than 3 times the upper limit of normal
- Total bilirubin less than 2 times the upper limit of normal (except Gilbert's syndrome)
- ALP 250 IU/L or less
- Left ventricular ejection fraction greater than 45%
- Adjusted diffusing capacity of the lungs for carbon monoxide greater than 50%
- Negative HIV test
- Negative pregnancy test confirmed by serum beta-hCG
- Willing to comply with all study procedures and available for the study duration
You will not qualify if you...
- Pregnant or nursing women, or women of childbearing potential unwilling to abstain from heterosexual sex or use effective contraception from conditioning start through 90 days after last study drug dose
- Male subjects unwilling to use effective barrier contraception or abstain from heterosexual intercourse during the same period
- Unable to provide informed consent
- Recent myocardial infarction within 6 months or severe heart conditions like NYHA Class III/IV heart failure, uncontrolled angina, severe arrhythmias, or active ECG abnormalities unless deemed not medically relevant
- Known allergies to any study drugs
- Serious medical or psychiatric illness interfering with study participation
- Diagnosis or treatment of another malignancy within 3 years, except certain low-risk cancers after curative therapy
- Participation in other investigational drug trials within 14 days before or 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.
Duration - Up to 2 years
Participants receive high-dose post-transplant cyclophosphamide, bortezomib, and abatacept as prophylaxis to prevent graft-versus-host disease following allogeneic hematopoietic stem cell transplantation.
Trial Site Locations
Total: 1 location
1
Zuckerberg Cancer Center
Lake Success, New York, United States, 11042
Actively Recruiting
Research Team
K
Kelli Cole
A
Ahmad Samer Al-Homsi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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