NCT04237623PHASE2Recruiting

GM-CSF With Post-Transplant Cyclophosphamide

Northside Hospital, Inc.

Start Date

5/18/2020

Completion Date

9/18/2026

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

Age Range: 18 years to 78 years

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

Interventions

DRUG

Sargramostim

OTHER

Control Arm

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Conditions

Transplant-Related Hematologic Malignancy

Locations

Northside Hospital

Atlanta, Georgia 30342

United States