Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075816
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2004-01-09
Brief Title:
Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers BMT CTN 0201
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
A Phase III Randomized Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell With Marrow Transplantation From Human Leukocyte Antigen HLA Compatible Unrelated Donors BMT CTN 0201
Status:
COMPLETED
Status Verified Date:
2022-12
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:
The study is designed as a Phase III randomized open label multicenter prospective comparative trial of granulocyte colony stimulating factor G-CSF-mobilized peripheral blood stem cells PBSC versus marrow from unrelated donors for transplantation in patients with hematologic malignancies Recipients will be stratified by transplant center and disease risk and will be randomized to either the PBSC or marrow arm in a 11 ratio
Detailed Description:
BACKGROUND
Many studies of allogeneic marrow transplantation have shown that a higher dose of marrow cells correlates with more robust hematopoietic engraftment and lower mortality from infectious complications Peripheral blood stem cells PBSC collected after mobilization with granulocyte colony stimulating factor G-CSF contain a larger number of CD34-positive CD34 progenitors and total cells than bone marrow These observations led to the hypothesis that transplantation of PBSC would lead to lower mortality compared to transplantation of marrow In addition PBSC grafts have a higher T cell content predicting a possibly more powerful anti-leukemia effect However the higher T cell content of PBSC may also lead to increased incidence and severity of acute and chronic graft-versus-host disease GVHD This concern is especially serious when the donor is unrelated to the recipient This prospective randomized multicenter clinical trial of unrelated donor transplantation will test the hypothesis that transplantation of PBSC leads to similar patient survival compared to transplantation of marrow
DESIGN NARRATIVE
This is a Phase III randomized open label multicenter clinical trial sponsored by the National Marrow Donor Program NMDP and the National Institutes of Health NIH The objective of the trial is to test the null hypothesis that there is no difference in overall survival after PBSC versus marrow transplants from HLA compatible unrelated donors The study will compare G-CSF-mobilized PBSC transplantation with bone marrow transplantation from HLA-compatible unrelated donors for patients with leukemia myelodysplastic or myeloproliferative syndromes Conditioning and GVHD prophylaxis regimens will vary by center and within centers however the center must declare before randomization what regimens will be used for each patient The primary endpoint of this trial is 2-year survival following randomization Secondary analyses will consider neutrophil and platelet recovery acute and chronic GVHD time off all immunosuppressive therapy relapse infections adverse events and immune reconstitution The trial will include evaluation of patient and donor quality of life composition of the graft and immune reconstitution Accrual is anticipated for 3 years with a follow-up period of 3 years
Many studies of allogeneic marrow transplantation have shown that a higher dose of marrow cells correlates with more robust hematopoietic engraftment and lower mortality from infectious complications Peripheral blood stem cells PBSC collected after mobilization with granulocyte colony stimulating factor G-CSF contain a larger number of CD34-positive CD34 progenitors and total cells than bone marrow These observations led to the hypothesis that transplantation of PBSC would lead to lower mortality compared to transplantation of marrow In addition PBSC grafts have a higher T cell content predicting a possibly more powerful anti-leukemia effect However the higher T cell content of PBSC may also lead to increased incidence and severity of acute and chronic graft-versus-host disease GVHD This concern is especially serious when the donor is unrelated to the recipient This prospective randomized multicenter clinical trial of unrelated donor transplantation will test the hypothesis that transplantation of PBSC leads to similar patient survival compared to transplantation of marrow
DESIGN NARRATIVE
This is a Phase III randomized open label multicenter clinical trial sponsored by the National Marrow Donor Program NMDP and the National Institutes of Health NIH The objective of the trial is to test the null hypothesis that there is no difference in overall survival after PBSC versus marrow transplants from HLA compatible unrelated donors The study will compare G-CSF-mobilized PBSC transplantation with bone marrow transplantation from HLA-compatible unrelated donors for patients with leukemia myelodysplastic or myeloproliferative syndromes Conditioning and GVHD prophylaxis regimens will vary by center and within centers however the center must declare before randomization what regimens will be used for each patient The primary endpoint of this trial is 2-year survival following randomization Secondary analyses will consider neutrophil and platelet recovery acute and chronic GVHD time off all immunosuppressive therapy relapse infections adverse events and immune reconstitution The trial will include evaluation of patient and donor quality of life composition of the graft and immune reconstitution Accrual is anticipated for 3 years with a follow-up period of 3 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U24CA076518 | NIH | Blood and Marrow Transplant Clinical Trials Network | httpsreporternihgovquickSearch5U24CA076518 |
| U01HL069294-05 | NIH | None | None |
| BMT CTN 0201 | OTHER | None | None |