GM-CSF With Post-Transplant Cyclophosphamide

Sponsor: Northside Hospital, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04237623

Patient View

This clinical trial evaluates GM-CSF post-transplant in patients with 5/10 to 8/10 matched related donors and a KPS ≥ 70%. Eligible conditions include various hematologic malignancies. Participants receive Sargramostim (250mcg/m2/day IV from Day +5) or standard G-CSF if they opt out of GM-CSF. The study aims to compare recovery rates and infection risks.

Patient Parameters

Program Overview

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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