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Study of Cyclophosphamide, Bortezomib, and Abatacept for GVHD Prevention

This study is testing a combination of three drugs – cyclophosphamide, bortezomib, and abatacept – to prevent Graft-versus-Host Disease (GVHD) after an allogeneic hematopoietic stem cell transplant (HSCT). GVHD is a complication where the donor's immune cells attack the patient's body. The study aims to find the safest and most effective dose of abatacept when given with the other two drugs. You might be able to join if you are at least 18 years old, have a good general health score (Karnofsky score ≥70%), and meet other health requirements like normal kidney and liver function. The study is currently recruiting about 10 participants.

Study design
This study has two parts: an initial phase to find the best drug dose, and a second phase to further test that dose. It is an open-label study, meaning both you and your doctors will know which treatments you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years after treatment.

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

NCT06681922

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Northwell Health
~10 participants
Updated 2024-12-16 on ClinicalTrials.gov
What's tested:Cyclophosphamide, Bortezomib, Abatacept

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the MTD of abatacept in combination with PTCy and bortezomib Determine the MTD of abatacept in combination with PTCy and bortezomib Determine the MTD of abatacept in combination with PTCy and bortezomib
Measured over Up to 2 years

Conditions

Graft Vs Host Disease

Explore related trials

Graft Versus Host Disease

Where it's being run

1 sites across 1 states
New York1

Who to contact

Kelli Cole
[email protected]
5167348900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥18 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)
ALP ≤250 IU/L
LVEF \>45%
Adjusted DLCO \>50%
Negative HIV serology
Negative pregnancy test: Confirmation per negative serum 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 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 consecutive months.
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.
Inability to provide informed consent.
Patient had myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, 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 is 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

  • Determine the MTD of abatacept in combination with PTCy and bortezomib Determine the MTD of abatacept in combination with PTCy and bortezomib Determine the MTD of abatacept in combination with PTCy and bortezomibUp to 2 years