Transplant-Related Hematologic Malignancy Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 38 |
Est. completion date | September 18, 2025 |
Est. primary completion date | September 18, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 78 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northside Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Northside Hospital, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 3 months after initial treatment | |
Secondary | 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 | |
Secondary | How many patients have not relapsed measured by relapse rates at 12 months following the initiation of treatment. | To estimate relapse rates | 12 months following initiation of treatment | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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