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RECRUITING
NCT04237623
PHASE2

GM-CSF With Post-Transplant Cyclophosphamide

Sponsor: Northside Hospital, Inc.

View on ClinicalTrials.gov

Summary

Given the increased number of HLA-mismatched haploidentical transplantation with post-transplant cyclophosphamide performed each year and the high risk of infectious complications associated with this type of transplant, the investigators suggest that GM-CSF administration post-infusion of T-replete haploidentical stem cells and post-transplant cyclophosphamide can yield similar count recovery rates to G-CSF with a potential of lowering risk of infectious complications.

Official title: Phase II Trial Evaluating the Efficacy and Safety of Sargramostim Post-Infusion of T-Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells and With Post Transplant Cyclophosphamide

Key Details

Gender

All

Age Range

18 Years - 78 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2020-05-18

Completion Date

2026-09-18

Last Updated

2025-10-30

Healthy Volunteers

No

Interventions

DRUG

Sargramostim

250mcg/m2/day IV starting Day +5

OTHER

Control Arm

Standard G-CSF given to those who decline to receive GM-CSF

Locations (1)

Northside Hospital

Atlanta, Georgia, United States