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

RecruitingPhase 1, Phase 2Ages 14 Years - 100 YearsAllNorthwell Health
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In plain words

What the trial is, and whether it could suit you

This is a phase I-II clinical trial. Adult subjects with hematological malignancies undergoing allogeneic HSCT from an HLA matched sibling or โ‰ฅ7 out of 8 allele level HLA matched unrelated donor are eligible for the study if they meet the criteria defined in our standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Subjects will receive a standard of care conditioning regimen. Subjects will receive investigational PTCy, investigational bortezomib and investigational abatacept as GvHD prophylaxis.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ14 years * Karnofsky score โ‰ฅ70% * 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 โ‰ค250 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 ฮฒ-human chorionic gonadotropin (ฮฒ-hCG) * Willing to comply with all study procedures and be available for the duration of the study. Exclusion Criteria: * 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
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What it tests

  • Cyclophosphamide
  • Abatacept
  • Bortezomib
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Where

1 site
Northwell Health
New Hyde Park, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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