High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

NCT ID: NCT03945591

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2024-01-04

Brief Summary

This is a single arm open label phase II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from matched-related or unrelated donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity or myeloablative conditioning regimen of fludarabine, busulfan, and rabbit anti-thymocyte globulin (rATG). Patients will receive PTCyBor as GvHD prophylaxis.

Conditions

GVHD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyclophosphamide and Bortezomib

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.

Cyclophosphamide

Intervention Type: DRUG

50 mg/kg IV over 2 hours on Day +3 and +4

Interventions

Bortezomib

1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.

Intervention Type: DRUG

Cyclophosphamide

50 mg/kg IV over 2 hours on Day +3 and +4

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Karnofsky score ≥ 70%
• No evidence of progressive bacterial, viral, or fungal infection
• Creatinine clearance > 50 mL/min/1.72m2
• Total bilirubin, ALT and AST < 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) > 60%
• Negative HIV serology
• Negative pregnancy test: confirmation per negative serum β-human chorionic gonadotropin (β-hCG)

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 the first dose of bortezomib through 90 days after the last dose. 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 during the entire study treatment period and 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 E), 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmad Al-Homsi, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-01185

Identifier Type: -

Identifier Source: org_study_id