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Recruiting Phase 2 NCT04237623

GM-CSF With Post-Transplant Cyclophosphamide

Trial Parameters

Condition Transplant-Related Hematologic Malignancy
Sponsor Northside Hospital, Inc.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 38
Sex ALL
Min Age 18 Years
Max Age 78 Years
Start Date 2020-05-18
Completion 2026-09-18
Interventions
SargramostimControl Arm

Brief 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 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

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