GM-CSF With Post-Transplant Cyclophosphamide
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-78
SponsorNorthside Hospital, Inc.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sargramostim
- Control Arm
Treatment groups
38 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov