GM-CSF With Post-Transplant Cyclophosphamide
- Conditions
- Transplant-Related Hematologic Malignancy
- Interventions
- Other: Control Arm
- Registration Number
- NCT04237623
- Lead Sponsor
- Northside Hospital, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GM-CSF post-transplant Control Arm Sargramostim (GM-CSF) will start on Day +5 and continue until ANC \>1000 x3 days or \>1500 x1 day. GM-CSF will be administered not less than 24 hours after the last dose of cyclophosphamide and will be given at a dose of 250mcg/m2/day as an infusion over 2 hours. GM-CSF post-transplant Sargramostim Sargramostim (GM-CSF) will start on Day +5 and continue until ANC \>1000 x3 days or \>1500 x1 day. GM-CSF will be administered not less than 24 hours after the last dose of cyclophosphamide and will be given at a dose of 250mcg/m2/day as an infusion over 2 hours.
- Primary Outcome Measures
Name Time Method The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment. 3 months after initial 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.
- Secondary Outcome Measures
Name Time Method How many patients have not relapsed measured by relapse rates at 12 months following the initiation of treatment. 12 months following initiation of treatment To estimate relapse rates
How many patients died due to infections measured by the incidence and type of infections at 12 months following initiation of treatment 12 months following initiation of treatment To estimate infection-related mortality
Number of patients achieving platelet engraftment as measured by platelets reaching 20,000 without transfusion for 7 days 12 months following initiation of treatment To assess time to platelet engraftment
How many patients died due to a treatment-related adverse events grade 2 or greater as assessed by CTCAE v.4.0 12 months following initiation of treatment To estimate event-free survival
Number of patients to achieve full donor chimerisms at Days 30, 50, 100, and 6 months post-transplant as measured by donor chimerism data 12 months following initiation of treatment To estimate graft failure
Number of patients that acquired an infection in the first 100-days post-transplant as measured by the incidence of infections 12 months following initiation of treatment To estimate the rate of infections
How many patients are still alive measured by overall survival at 12 months following the initiation of treatment. 12 months following initiation of treatment To estimate overall survival
How many patients develop graft-versus-host-disease (GVHD) measured by the incidence of GVHD at 12 months following initiation of treatment 12 months following initiation of treatment To estimate incidence of GVHD
How many patients have not relapsed measured by progression-free survival at 12 months following the initiation of treatment 12 months following initiation of treatment To estimate non-relapse mortality
Trial Locations
- Locations (1)
Northside Hospital
🇺🇸Atlanta, Georgia, United States