Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329030
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2006-05-22
Brief Title:
RituxanBEAM vs BexxarBEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkins Lymphoma BMTCTN0401
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Phase III RituxanBEAM vs BexxarBEAM With Autologous Hematopoietic Stem Cell Transplantation ASCT for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-cell Non-Hodgkins Lymphoma BMTCTN0401
Status:
COMPLETED
Status Verified Date:
2017-08
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 study is designed as a Phase III multicenter trial comparing progression-free survival PFS after autologous hematopoietic stem cell transplantation using a standard Rituxan plus BEAM transplant regimen versus a regimen adding Bexxar to BEAM
Detailed Description:
BACKGROUND
Bexxar Tositumomab and Iodine I 131 Tositumomab is a radioimmunoconjugate with demonstrated anti-lymphoma effects This drug is indicated for the treatment of patients with CD20 positive relapsed or refractory low grade follicular or transformed non-Hodgkins lymphoma including patients with Rituximab-refractory non-Hodgkins lymphoma Bexxar has been used in several Phase I and II transplant trials either alone or in combination with high-dose chemotherapy for the treatment of relapsed non-Hodgkins lymphoma The Phase I and II trials combining Bexxar with BEAM and autologous hematopoietic stem cell transplantation demonstrated promising early results with 80 event-free survival in relapsed chemosensitive diffuse large B-cell non-Hodgkins lymphoma patients The administration of Rituxan to the mobilization and conditioning regimen is now the standard of care at most transplant centers Therefore the primary endpoint of this study will be to compare progression-free survival after autologous hematopoietic stem cell transplantation for chemotherapy-sensitive diffuse large B-cell lymphoma using RituxanBEAM versus BexxarBEAM for pre-transplant conditioning
DESIGN NARRATIVE
All patients will receive induction or salvage chemotherapy as indicated by their clinical circumstance to achieve at least a partial response as defined in the protocol There must be 20 or less bone marrow involvement after their most recent salvage therapy
Mobilization therapy may be employed per institutional guidelines but all patients must receive one dose of rituxan 375 mgm2 at least within 4 weeks of actual stem cell apheresis Patients must have an adequate autograft target of at least 20 X 106 CD34 cellskg minimum of more than 15 X 106 CD34 cellskg to be eligible for the protocol Eligible patients will be randomized to receive either 1 Rituxan plus BEAM with Rituxan 375 mgm2 IV Days -19 and -12 Carmustine BCNU 300 mgm2 Day -6 Etoposide 100 mgm2 Days -5 to -2 Cytarabine 100 mgm2 Days -5 to -2 and Melphalan 140 mgm2 Day -1 followed by ASCT or 2 BexxarBEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose TBD on Day -12 Patients will then receive BCNU 300 mgm2 Day -6 Etoposide 100 mgm2 Days -5 to -2 Cytarabine 100 mgm2 Days -5 to -2 and Melphalan 140 mgm2 Day -1 followed by ASCT
Patients will be followed for 2 years post-transplant Survival data hematopoiesis data incidence of infection mucositis assessment data immune reconstitution data and toxicity data will be recorded and reported periodically to the BMT CTN Data Coordinating Center DCC
Bexxar Tositumomab and Iodine I 131 Tositumomab is a radioimmunoconjugate with demonstrated anti-lymphoma effects This drug is indicated for the treatment of patients with CD20 positive relapsed or refractory low grade follicular or transformed non-Hodgkins lymphoma including patients with Rituximab-refractory non-Hodgkins lymphoma Bexxar has been used in several Phase I and II transplant trials either alone or in combination with high-dose chemotherapy for the treatment of relapsed non-Hodgkins lymphoma The Phase I and II trials combining Bexxar with BEAM and autologous hematopoietic stem cell transplantation demonstrated promising early results with 80 event-free survival in relapsed chemosensitive diffuse large B-cell non-Hodgkins lymphoma patients The administration of Rituxan to the mobilization and conditioning regimen is now the standard of care at most transplant centers Therefore the primary endpoint of this study will be to compare progression-free survival after autologous hematopoietic stem cell transplantation for chemotherapy-sensitive diffuse large B-cell lymphoma using RituxanBEAM versus BexxarBEAM for pre-transplant conditioning
DESIGN NARRATIVE
All patients will receive induction or salvage chemotherapy as indicated by their clinical circumstance to achieve at least a partial response as defined in the protocol There must be 20 or less bone marrow involvement after their most recent salvage therapy
Mobilization therapy may be employed per institutional guidelines but all patients must receive one dose of rituxan 375 mgm2 at least within 4 weeks of actual stem cell apheresis Patients must have an adequate autograft target of at least 20 X 106 CD34 cellskg minimum of more than 15 X 106 CD34 cellskg to be eligible for the protocol Eligible patients will be randomized to receive either 1 Rituxan plus BEAM with Rituxan 375 mgm2 IV Days -19 and -12 Carmustine BCNU 300 mgm2 Day -6 Etoposide 100 mgm2 Days -5 to -2 Cytarabine 100 mgm2 Days -5 to -2 and Melphalan 140 mgm2 Day -1 followed by ASCT or 2 BexxarBEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose TBD on Day -12 Patients will then receive BCNU 300 mgm2 Day -6 Etoposide 100 mgm2 Days -5 to -2 Cytarabine 100 mgm2 Days -5 to -2 and Melphalan 140 mgm2 Day -1 followed by ASCT
Patients will be followed for 2 years post-transplant Survival data hematopoiesis data incidence of infection mucositis assessment data immune reconstitution data and toxicity data will be recorded and reported periodically to the BMT CTN Data Coordinating Center DCC
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 |
|---|---|---|---|
| BMT CTN 0401 | OTHER | None | None |
| U01HL069294-05 | NIH | None | None |
| 384 | OTHER | BMT CTN | httpsreporternihgovquickSearchU01HL069294-05 |