Phase II Trial Evaluating the Efficacy and Safety of Sargramostim Post-Infusion of T-Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells and With Post Transplant Cyclophosphamide
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.
Arms & interventions
- DrugSargramostim
250mcg/m2/day IV starting Day +5
- OtherControl Arm
Standard G-CSF given to those who decline to receive GM-CSF
Outcome measures
Primary
The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment.
The aim of the study is to establish equivalent effectiveness of Sargramostim to a matched control cohort of G-CSF treated patients in time to achieve neutrophil (ANC \>500 x3 days) post infusion of HLA-mismatched peripheral blood haploidentical stem cells with post-transplant cyclophosphamide. Patients will be followed for 3 months following the initiation of treatment to see engraftment numbers at 20 days after initial treatment.
Time frame: 3 months after initial treatment
Secondary
How many patients are still alive measured by overall survival at 12 months following the initiation of treatment.
Time frame: 12 months following initiation of treatment
How many patients have not relapsed measured by relapse rates at 12 months following the initiation of treatment.
Time frame: 12 months following initiation of treatment
How many patients develop graft-versus-host-disease (GVHD) measured by the incidence of GVHD at 12 months following initiation of treatment
Time frame: 12 months following initiation of treatment
How many patients have not relapsed measured by progression-free survival at 12 months following the initiation of treatment
Time frame: 12 months following initiation of treatment
How many patients died due to infections measured by the incidence and type of infections at 12 months following initiation of treatment
Time frame: 12 months following initiation of treatment
How many patients died due to a treatment-related adverse events grade 2 or greater as assessed by CTCAE v.4.0
Time frame: 12 months following initiation of treatment
Number of patients to achieve full donor chimerisms at Days 30, 50, 100, and 6 months post-transplant as measured by donor chimerism data
Time frame: 12 months following initiation of treatment
Number of patients that acquired an infection in the first 100-days post-transplant as measured by the incidence of infections
Time frame: 12 months following initiation of treatment
Number of patients achieving platelet engraftment as measured by platelets reaching 20,000 without transfusion for 7 days
Time frame: 12 months following initiation of treatment
Eligibility criteria
Study locations (1)
Northside Hospital
Atlanta, Georgia, 30342