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GM-CSF With Post-Transplant Cyclophosphamide

NCT04237623 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-04-16

No results posted yet for this study

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

DRUG

Sargramostim

250mcg/m2/day IV starting Day +5

OTHER

Control Arm

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

Sponsors & Collaborators

  • Northside Hospital, Inc.

    lead OTHER

Principal Investigators

  • Melhem Solh, MD · Northside Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-05-18
Primary Completion
2026-09-18
Completion
2026-09-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04237623 on ClinicalTrials.gov