Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006241
Status:
COMPLETED
Last Update Posted:
2011-11-30
First Post:
2000-09-11
Brief Title:
Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Low- or Intermediate-Grade Non-Hodgkins Lymphoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Pivotal Study to Determine the Safety and Efficacy of Using B-Cell High Density Microparticles BCell-HDM to Deplete B-Cells From Peripheral Blood Stem Cell Collections Without Compromising the Time to Neutrophil and Platelet Engraftment in Patients With Relapsed Low or Intermediate Grade B-Cell Non-Hodgkins Lymphoma Given Autologous Peripheral Blood Stem Cell Transplants After High-Dose Chemotherapy
Status:
COMPLETED
Status Verified Date:
2011-11
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:
RATIONALE Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy Treating the peripheral stem cells in the laboratory to remove any existing cancer cells may improve the effectiveness of the transplant
PURPOSE Randomized phase II trial to compare the effectiveness of treated peripheral stem cells with that of untreated stem cells in patients who have relapsed low- or intermediate-grade non-Hodgkins lymphoma
PURPOSE Randomized phase II trial to compare the effectiveness of treated peripheral stem cells with that of untreated stem cells in patients who have relapsed low- or intermediate-grade non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the effectiveness of the B-cell high density microparticles BCell-HDM device in purging B-cells from peripheral blood stem cells PBSC harvested from patients with relapsed low or intermediate grade B-cell non-Hodgkins lymphoma II Determine the recovery of T-cells and CD34 cells in BCell-HDM processed PBSC in these patients III Compare hematopoietic engraftment following infusion of autologous PBSC purged using the BCell-HDM device versus unpurged autologous PBSC in these patients receiving high dose chemotherapy IV Determine the toxicity of this regimen in these patients V Determine the occurrence of adverse effects from this regimen in these patients
OUTLINE This is a randomized double blind multicenter study Patients are stratified by grade of lymphoma low vs intermediate type of myeloablative conditioning regimen chemotherapy only vs chemotherapytotal body irradiation and center Patients are randomized to one of two treatment arms Patients undergo peripheral blood stem cell PBSC harvest over no more than 4 consecutive days A myeloablative conditioning regimen of either chemotherapy alone or chemotherapytotal body irradiation is given within 4 weeks of PBSC harvest Prior to randomization one patient at each center receives PBSC transplantation using cells purged with the B-cell high density microparticle BCell-HDM device Arm I Patients receive BCell-HDM treated PBSC transplantation on day 0 Arm II Patients receive untreated PBSC transplantation on day 0 Patients receive filgrastim G-CSF subcutaneously beginning on day 1 and continuing until blood counts recover Patients are followed on days 30 and 100 and then at 6 and 12 months
PROJECTED ACCRUAL A total of 115 patients 15 for prerandomization study 50 for each treatment arm will be accrued for this study
OUTLINE This is a randomized double blind multicenter study Patients are stratified by grade of lymphoma low vs intermediate type of myeloablative conditioning regimen chemotherapy only vs chemotherapytotal body irradiation and center Patients are randomized to one of two treatment arms Patients undergo peripheral blood stem cell PBSC harvest over no more than 4 consecutive days A myeloablative conditioning regimen of either chemotherapy alone or chemotherapytotal body irradiation is given within 4 weeks of PBSC harvest Prior to randomization one patient at each center receives PBSC transplantation using cells purged with the B-cell high density microparticle BCell-HDM device Arm I Patients receive BCell-HDM treated PBSC transplantation on day 0 Arm II Patients receive untreated PBSC transplantation on day 0 Patients receive filgrastim G-CSF subcutaneously beginning on day 1 and continuing until blood counts recover Patients are followed on days 30 and 100 and then at 6 and 12 months
PROJECTED ACCRUAL A total of 115 patients 15 for prerandomization study 50 for each treatment arm will be accrued for this study
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 |
|---|---|---|---|
| CDR0000068166 | REGISTRY | PDQ | None |
| FHCRC-148800 | None | None | None |
| ELIGIX-C99-105 | None | None | None |
| NCI-G00-1846 | None | None | None |