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Preventing GvHD After Transplant with Cyclophosphamide, Bortezomib, and Abatacept

This study is testing if a combination of three drugs—Cyclophosphamide, Bortezomib, and Abatacept—can help prevent Graft-versus-Host Disease (GvHD) in people receiving a stem cell transplant for blood cancers. GvHD is a serious complication where the new immune cells attack your body. You may be able to join if you are 14 to 100 years old, have certain blood cancers, and are having a stem cell transplant from a matched donor. The study aims to find the safest dose of Abatacept and see how well this drug combination prevents severe GvHD. The current recruitment status is unclear.

Study design
This is a Phase I-II interventional study planning to enroll 74 participants. It will first find the best dose of Abatacept (Phase I) and then test its effectiveness (Phase II).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment prevents GvHD for up to 120 days after your transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05289167

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

Recruiting
PHASE1Ages 14+InterventionalTreatment
Northwell Health
~74 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:CyclophosphamideAbataceptBortezomib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I:Incidence Dose limiting toxicity (DLT)
Measured over Day+1 to Day +120
+1 more outcome measured

Conditions

Graft-versus-host Disease

Explore related trials

Hematologic Neoplasm

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • A. Samer Al-Homsi, MD, MBA · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Kelli Cole
[email protected]
516-734-8973
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥14 years
Karnofsky score ≥70%
No evidence of progressive bacterial, viral, or fungal infection
Creatinine clearance \>50 mL/min/1.72m2
ALT and AST \<3 x the upper limit of normal
Total bilirubin \<2 x the upper limit of normal (except for Gilbert's syndrome)
Alkaline phosphatase ≤250 IU/L
Left Ventricular Ejection Fraction (LVEF) \>45%
Adjusted Carbon Monoxide Diffusing Capacity (DLCO) \>50%
Negative HIV serology
Negative pregnancy test: Confirmation per negative serum β-human chorionic gonadotropin (β-hCG)
Willing to comply with all study procedures and be available for the duration of the study.

Exclusion

Pregnant or nursing females or women of reproductive capability who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from start of conditioning through 90 days after the last dose of study drug. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row.
Male subjects who refuse to practice effective barrier contraception from the start of conditioning through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (i.e., post-vasectomy).
Inability to provide informed consent.
Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix D), 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.
Known allergies to any of the components of the investigational treatment regimen.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma, an in-situ malignancy, or low-risk prostate cancer after curative therapy.
Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
Prisoners
Pregnant women

What this trial measures

  • Phase I:Incidence Dose limiting toxicity (DLT)Day+1 to Day +120

    Defined as grade 4 non-hematologic toxicity affecting the oral cavity, gastrointestinal tract, lung, heart, liver, kidney, bladder, or central nervous system.

  • Phase II: Grades II-IV Acute GvHDDay+1 to Day +120

    The first day of grades II-IV acute GvHD will be recorded for that grade. This end point will be evaluated through day +120 post-transplant.