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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

Who can join

Ages 18 to 78 · All sexes

Inclusion Criteria:

* Availability of 5/10 to 8/10 matched related donor
* KPS \>/= 70%
* CML, AML, MDS, ALL, CLL, HD, NHL, MPS/CMML, MM, any other hematologic condition deemed an eligible indication for allogeneic transplant by the treating center

Exclusion Criteria:

* Poor cardiac, pulmonary, liver, and renal function
* HIV-positive
* Patients who have a debilitating medical or psychiatric illness that would preclude them from giving informed consent
* History of severe or serious allergic reaction to human GM-CSF or yeast-derived products

About the study

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.

What is being tested

• Sargramostim (drug)
• Control Arm (other)

Sponsor: Northside Hospital, Inc. · Participants: 38 · Started: May 18, 2020

Contact the study team

• Stacey Brown, BA · Phone: 404-780-7965

Official record on ClinicalTrials.gov — NCT04237623

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.