Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01385787
Status:
COMPLETED
Last Update Posted:
2017-09-07
First Post:
2011-06-28
Brief Title:
MRD Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia
Sponsor:
Center for International Blood and Marrow Transplant Research
Organization:
Center for International Blood and Marrow Transplant Research
Study Overview
Official Title:
The Role of Minimal Residual Disease Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2017-09
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:
This is a non-therapeutic study Pediatric AML patients undergoing HCT with a myeloablative preparative regimen may be enrolled Subjects can be enrolled 10-40 days prior to HCT Three samples for MRD measured by WT1 PCR and flow cytometry will be collected from peripheral blood and bone marrow 1 pre-HCT 3 weeks prior to starting the preparative regimen 2 day 42 - 14 days post HCT early post-engraftment and 3 day 100 -20 days post HCT For two years after transplant the subjects follow-up data will be collected using the Research Level Forms in the CIBMTR Forms Net internet data entry system The main objective is to determine whether there is any association between level of pre-transplant and post-transplant bone marrow MRD using WT1 and flow cytometry with 2-year event-free-survival and to estimate the strength of that association in terms of the predictive accuracy of MRD The investigators hypothesize that measurable MRD at either time point will be associated with decreased 2-year event-free survival
Detailed Description:
This is a prospective non-therapeutic study assessing the significance of minimal residual disease MRD at three different time points in relation to allogeneic HCT for pediatric AML The study is a collaboration between the Pediatric Blood and Marrow Transplant Consortium PBMTC and the Resource for Clinical Investigations in Blood and Marrow Transplantation RCI-BMT of the Center for International Blood and Marrow Transplant Research CIBMTR The study will enroll pediatric AML patients who undergo myeloablative HCT at PBMTC sites The eligibility criteria for this non-therapeutic study mirror widely accepted criteria for allogeneic HCT in pediatric AML
The study tests the hypothesis that assessment of pre-transplant and post-transplant MRD predicts 2-year outcomes following transplant Two MRD methodologies are being studied flow cytometry and WT1 PCR The secondary hypothesis is that combining these 2 methodologies will improve the accuracy in predicting 2-year outcomes following transplant
It is well established that the level of minimal residual disease MRD during chemotherapy is a strong predictor of relapse in children with acute lymphoblastic leukemia ALL 33 34 Within this population MRD levels have the potential to predict those patients who will respond well to standard therapy thus allowing clinicians to tailor therapy and minimize toxicity while ensuring maximal cure rates 10 MRD levels before allogeneic hematopoietic stem cell transplantation HCT also predict the risk of relapse post-HCT 25 leading to the clinical practice of reducing MRD levels as much as possible before transplant By contrast in children with acute myeloid leukemia AML the prognostic value of MRD levels prior to HCT remains unclear
Our long-term objective is to improve the cure rate for children with AML The investigators hypothesize that MRD levels before HCT will provide a powerful tool to select the best candidates for transplant guide decision making in stem cell source and preparative therapy and optimize the timing of the transplant Measurements of MRD post-HCT will allow informed decisions about withdrawal of immunosuppressive therapy administration of donor lymphocyte infusions or alternative targeted therapies
The study tests the hypothesis that assessment of pre-transplant and post-transplant MRD predicts 2-year outcomes following transplant Two MRD methodologies are being studied flow cytometry and WT1 PCR The secondary hypothesis is that combining these 2 methodologies will improve the accuracy in predicting 2-year outcomes following transplant
It is well established that the level of minimal residual disease MRD during chemotherapy is a strong predictor of relapse in children with acute lymphoblastic leukemia ALL 33 34 Within this population MRD levels have the potential to predict those patients who will respond well to standard therapy thus allowing clinicians to tailor therapy and minimize toxicity while ensuring maximal cure rates 10 MRD levels before allogeneic hematopoietic stem cell transplantation HCT also predict the risk of relapse post-HCT 25 leading to the clinical practice of reducing MRD levels as much as possible before transplant By contrast in children with acute myeloid leukemia AML the prognostic value of MRD levels prior to HCT remains unclear
Our long-term objective is to improve the cure rate for children with AML The investigators hypothesize that MRD levels before HCT will provide a powerful tool to select the best candidates for transplant guide decision making in stem cell source and preparative therapy and optimize the timing of the transplant Measurements of MRD post-HCT will allow informed decisions about withdrawal of immunosuppressive therapy administration of donor lymphocyte infusions or alternative targeted therapies
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