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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GM-CSF post-transplant | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sargramostim | Drug | 250mcg/m2/day IV starting Day +5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| How many patients are still alive measured by overall survival at 12 months following the initiation of treatment. | To estimate overall survival | 12 months following initiation of treatment |
| How many patients have not relapsed measured by relapse rates at 12 months following the initiation of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stacey Brown, BA | Contact | 404-780-7965 | stacey.brown@northside.com |
| Name | Affiliation | Role |
|---|---|---|
| Melhem Solh, MD | Northside Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
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| ID | Term |
|---|---|
| C081222 | sargramostim |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Control Arm | Other | Standard G-CSF given to those who decline to receive GM-CSF |
|
|
To estimate relapse rates |
| 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 | To estimate incidence of GVHD | 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 | To estimate non-relapse mortality | 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 | To estimate infection-related mortality | 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 | To estimate event-free survival | 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 | To estimate graft failure | 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 | To estimate the rate of infections | 12 months following initiation of treatment |
| Number of patients achieving platelet engraftment as measured by platelets reaching 20,000 without transfusion for 7 days | To assess time to platelet engraftment | 12 months following initiation of treatment |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |