Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003874
Status:
COMPLETED
Last Update Posted:
2011-11-29
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase III Study of Combined Enrichment of CD34 Cells and Depletion of B-Cells From Peripheral Blood Stem Cell Components for Patients With B-Lymphoid Malignancies
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 Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances without harming normal cells
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy in treating patients who have lymphoma or leukemia
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy in treating patients who have lymphoma or leukemia
Detailed Description:
OBJECTIVES I Evaluate the efficiency of tumor cell removal by immunomagnetic technique in patients with B cell malignancies II Determine toxicity of mobilized peripheral blood stem cell PBSC components of enriched CD34 and depleted B cells in this patient population III Compare recovery with the use of this treatment regimen to the use of unmanipulated PBSC or CD34 PBSC components in this patient population
OUTLINE Patients are assigned to one of two treatment arms for chemotherapy chemotherapy protocol following FHCRC-5062 Patients undergo mobilization and isolation of CD34 cells as described in FHCRC-5062 Peripheral blood stem cells are collected by apheresis and the CD34 cells are isolated using magnetic beads Monoclonal antibodies to CD19 and CD20 are added to the CD34 cells to sensitize any remaining tumor cells Patients undergo transplantation on day 0 according to applicable transplant protocols one month after mobilization Some patients may receive posttransplant interleukin-2 after achieving durable engraftment Patients are followed at day 30 80 180 365 and 395
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study
OUTLINE Patients are assigned to one of two treatment arms for chemotherapy chemotherapy protocol following FHCRC-5062 Patients undergo mobilization and isolation of CD34 cells as described in FHCRC-5062 Peripheral blood stem cells are collected by apheresis and the CD34 cells are isolated using magnetic beads Monoclonal antibodies to CD19 and CD20 are added to the CD34 cells to sensitize any remaining tumor cells Patients undergo transplantation on day 0 according to applicable transplant protocols one month after mobilization Some patients may receive posttransplant interleukin-2 after achieving durable engraftment Patients are followed at day 30 80 180 365 and 395
PROJECTED ACCRUAL A total of 20-30 patients 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 |
|---|---|---|---|
| CDR0000067039 | REGISTRY | PDQ | None |
| FHCRC-134500 | None | None | None |
| NCI-G99-1514 | None | None | None |