NCT04237623

GM-CSF With Post-Transplant Cyclophosphamide

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Northside Hospital, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transplant-Related Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	Sargramostim	250mcg/m2/day IV starting Day +5
OTHER	Control Arm	Standard G-CSF given to those who decline to receive GM-CSF

Timeline

• Start date: 2020-05-18
• Primary completion: 2026-09-18
• Completion: 2026-09-18
• First posted: 2020-01-23
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study