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

NCT05289167 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-12-27

No results posted yet for this study

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 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.

Conditions

  • Graft-versus-host Disease

Interventions

DRUG

Cyclophosphamide

50 mg/kg IV over 1 hour on Day +3 and +4

DRUG

Abatacept

Dose level 0: 10 mg/kg IV over 30 minutes on day +5 Dose level 1: 10mg/kg IV over 30 minutes on day +5 and +14 Dose level 2: 10mg/kg IV over 30 minutes on day +5, +14, and +28

DRUG

Bortezomib

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

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-13
Primary Completion
2025-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05289167 on ClinicalTrials.gov