Transplant-Related Hematologic Malignancy
Conditions
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.
Interventions
OTHERControl Arm
Standard G-CSF given to those who decline to receive GM-CSF
DRUGSargramostim
250mcg/m2/day IV starting Day +5
Sponsors
Northside Hospital, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Contacts
CONTACTStacey Brown, BA
PRINCIPAL_INVESTIGATORMelhem Solh, MD
Northside Hospital
Outcome results
None listed