GM-CSF With Post-Transplant Cyclophosphamide

• Status: Recruiting
• Trial end date: 2024-05-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northside Hospital, Inc.
• Treatments: Cyclophosphamide; Sargramostim

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