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
Northside Hospital, Inc.
38 participants
May 18, 2020
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
Inclusion Criteria3
- 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 Criteria4
- 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
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Interventions
250mcg/m2/day IV starting Day +5
Standard G-CSF given to those who decline to receive GM-CSF
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04237623