Ignite Creation Date:
2024-05-05 @ 10:07 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01036009
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2009-12-17
Brief Title:
A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase II Study of Preemptive Fast Withdrawal of Immunosuppression and Donor Lymphocyte Infusions for Achieving Complete Donor Chimerism Following Allogeneic Transplant for Pediatric Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is no curative therapy once acute leukemia patients relapse after transplant Patients who develop clinically significant graft versus host disease GVHD have a lower rate of relapse than those who do not develop GVHD We are initiating this study of post-transplant fast withdrawal of immunosuppression and donor lymphocyte infusions with a goal of achieving full donor chimerism in children with hematologic malignancies If our hypothesis that full donor chimerism results in leukemia-free survival is correct using immune modulation to achieve full donor chimerism should decrease relapse rate and thus increase survival The goal of this Phase II study is to identify if achieving full donor chimerism in whole blood CD3 and leukemia-specific CD1415 CD19 CD33 and CD34 subset may decrease the risk of relapse of patients undergoing allogeneic transplant for hematologic malignancy
Detailed Description:
The goal of this Phase II study is to identify if achieving full donor chimerism in whole blood CD3 and leukemia-specific subset CD3 CD1415 CD19 CD33 and CD34 subset may decrease the risk of relapse of patients undergoing allogeneic transplant for hematologic malignancy
We estimate that total of 50 recipient patients will need to be enrolled Of these 50 recipient patients an observation group and an intervention group will be formed We want to enroll 25 recipient patients in the intervention group this group will receive study intervention and their outcomes will be the focus of statistical analysis for this study Intervention will involve fast withdrawal of immunosuppression following transplant and donor lymphocyte infusion DLI until full donor chimerism is achieved Chimerism is a genetic test that measures the proportion of donors and recipients cells in blood or bone marrow Twenty five patients will undergo fast withdrawal of immunosuppression and 33 -50 of them 8-13 will undergo DLI following fast withdrawal of immunosuppression
Patients will have peripheral blood PB chimerism tested upon engraftment A confirmatory test from PB and bone marrow BM will be done on day 457 Minimal residual disease MRD will be examined by immunoflow FISH cytogenetics or PCR Patients with positive MRD will be on a faster schedule of immune intervention than patients with negative MRD Interventions will be carried on until 1 year post transplant If confirmatory testing shows no evidence of MRD and full donor chimerism is present in all subsets the patient will be part of the observation group and be observed until 2 years post transplant Chimerism will be repeated at 12 and 24 months post transplant If the patient has mixed chimerism on both confirmatory tests PB and BM the patient will be part of the intervention group and fast withdrawal of immunosuppression will be initiated If the patient has mixed chimerism on one of the confirmatory tests PB or BM the test will be repeated in 2 weeks and the patient will proceed with either observation or intervention based on the result of the repeated test Patients will be followed for the incidence of acute and chronic Graft Versus Host Disease GVHD and relapse until 2 years post transplant The study will be considered successful if the relapse rate at 2 years post transplant is 20 for the entire study or 40 for the intervention group
We estimate that total of 50 recipient patients will need to be enrolled Of these 50 recipient patients an observation group and an intervention group will be formed We want to enroll 25 recipient patients in the intervention group this group will receive study intervention and their outcomes will be the focus of statistical analysis for this study Intervention will involve fast withdrawal of immunosuppression following transplant and donor lymphocyte infusion DLI until full donor chimerism is achieved Chimerism is a genetic test that measures the proportion of donors and recipients cells in blood or bone marrow Twenty five patients will undergo fast withdrawal of immunosuppression and 33 -50 of them 8-13 will undergo DLI following fast withdrawal of immunosuppression
Patients will have peripheral blood PB chimerism tested upon engraftment A confirmatory test from PB and bone marrow BM will be done on day 457 Minimal residual disease MRD will be examined by immunoflow FISH cytogenetics or PCR Patients with positive MRD will be on a faster schedule of immune intervention than patients with negative MRD Interventions will be carried on until 1 year post transplant If confirmatory testing shows no evidence of MRD and full donor chimerism is present in all subsets the patient will be part of the observation group and be observed until 2 years post transplant Chimerism will be repeated at 12 and 24 months post transplant If the patient has mixed chimerism on both confirmatory tests PB and BM the patient will be part of the intervention group and fast withdrawal of immunosuppression will be initiated If the patient has mixed chimerism on one of the confirmatory tests PB or BM the test will be repeated in 2 weeks and the patient will proceed with either observation or intervention based on the result of the repeated test Patients will be followed for the incidence of acute and chronic Graft Versus Host Disease GVHD and relapse until 2 years post transplant The study will be considered successful if the relapse rate at 2 years post transplant is 20 for the entire study or 40 for the intervention group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None