Status:
ACTIVE_NOT_RECRUITING
Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD)
Lead Sponsor:
Northwell Health
Conditions:
Graft-versus-host Disease
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase I-II clinical trial. Adult subjects with hematological malignancies undergoing allogeneic HSCT from an HLA matched sibling or ≥7 out of 8 allele level HLA matched unrelated donor are e...
Detailed Description
The study will have a phase I and phase II potions. The phase I portion will employ a 3+3 dose escalation design to define the maximum tolerated dose (MTD) of abatacept added to PTCy and bortezomib fo...
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)
- 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
Key Trial Info
Start Date :
March 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05289167
Start Date
March 13 2022
End Date
December 1 2027
Last Update
December 27 2024
Active Locations (1)
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1
Northwell Health
New Hyde Park, New York, United States, 10016