RecruitingPhase 2NCT04237623

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

Sponsor

Northside Hospital, Inc.

Enrollment

38 participants

Start Date

May 18, 2020

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 YearsMax Age: 78 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Control Arm and a drug called Sargramostim for people with transplant-related hematologic malignancy. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 78 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSargramostim

250mcg/m2/day IV starting Day +5

OTHERControl Arm

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

Locations(1)

Northside Hospital

Atlanta, Georgia, United States

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NCT04237623