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Biological

High-Dose Post-Transplant Medication for Preventing Transplant Complications

Phase 1 & 2
Recruiting
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Karnofsky score ≥70%
Must not have
Inability to provide informed consent.
Patient had myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure (see Appendix C), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will be conducted in two phases. The first phase will determine the highest safe dose of abatacept in combination with PTCy and bortezomib after stem cell transplant. The

Who is the study for?
This trial is for individuals who have undergone a hematopoietic stem cell transplant (HSCT) and are at risk of developing graft-versus-host disease (GVHD). Participants must meet certain health criteria to be eligible.
What is being tested?
The study tests high doses of post-transplant medication, specifically abatacept combined with PTCy and bortezomib. It aims to find the safest dose that prevents GVHD after HSCT, using two separate study phases for different donor matches.
What are the potential side effects?
Potential side effects may include reactions related to immune suppression such as increased infection risk, possible drug-specific effects like blood pressure changes or liver enzyme alterations, and general symptoms like fatigue or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am mostly able to care for myself.
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I do not have any worsening infections.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am able to understand and agree to the study's procedures and risks.
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I haven't had a heart attack or severe heart issues in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
475 Previous Clinical Trials
469,274 Total Patients Enrolled
~7 spots leftby Oct 2027
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