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RECRUITING Phase 2 ClinicalTrials.gov

GM-CSF With Post-Transplant Cyclophosphamide

Sponsor: Northside Hospital, Inc. • ClinicalTrials.gov ID: NCT04237623

Registry updated: 2026-10-14
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Description

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.

Interventions

  • Sargramostim (Drug)
    250mcg/m2/day IV starting Day +5
  • Control Arm (Other)
    Standard G-CSF given to those who decline to receive GM-CSF

Eligibility criteria

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

Conditions

Transplant-Related Hematologic Malignancy

Locations

  • Northside Hospital — Atlanta, Georgia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record