Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031642
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2002-03-08
Brief Title:
Monoclonal Antibody Therapy in Relapsed Non-Hodgkins After Chemotherapy and Autologous Stem Cell Transplantation
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Phase III Study of IDEC-Y2B8 Zevalin for Post Transplant Relapses of B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-12
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:
RATIONALE Monoclonal antibodies such as rituximab can locate cancer cells and deliver cancer-killing substances to them without harming normal cells Radiolabeled monoclonal antibodies can locate and deliver radioactive cancer-killing substances
PURPOSE Phase III trial to study the effectiveness of combining radiolabeled monoclonal antibodies with rituximab in treating patients who have non-Hodgkins lymphoma that has not responded to high-dose chemotherapy and autologous stem cell transplantation
PURPOSE Phase III trial to study the effectiveness of combining radiolabeled monoclonal antibodies with rituximab in treating patients who have non-Hodgkins lymphoma that has not responded to high-dose chemotherapy and autologous stem cell transplantation
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of yttrium Y 90-labeled ibritumomab tiuxetan when administered with rituximab in patients with B-cell non-Hodgkins lymphoma who have relapsed after high-dose chemotherapy and autologous hematopoietic stem cell transplantation
Determine the safety and efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study of yttrium Y 90-labeled ibritumomab tiuxetan IDEC-Y2B8
Phase I Patients receive rituximab IV over 4-6 hours followed by indium In 111-labeled ibritumomab tiuxetan IDEC-In2B8 IV over 10 minutes on day 0 Patients receive rituximab IV again on day 7 followed by IDEC-Y2B8 IV over 10 minutes
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity
Phase II Once the MTD is determined 58 additional patients are treated at that dose level as in phase I
Patients are followed at 6 weeks every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 78 patients 20 for phase I and 58 for phase II will be accrued for this study within 2 years
Determine the maximum tolerated dose of yttrium Y 90-labeled ibritumomab tiuxetan when administered with rituximab in patients with B-cell non-Hodgkins lymphoma who have relapsed after high-dose chemotherapy and autologous hematopoietic stem cell transplantation
Determine the safety and efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study of yttrium Y 90-labeled ibritumomab tiuxetan IDEC-Y2B8
Phase I Patients receive rituximab IV over 4-6 hours followed by indium In 111-labeled ibritumomab tiuxetan IDEC-In2B8 IV over 10 minutes on day 0 Patients receive rituximab IV again on day 7 followed by IDEC-Y2B8 IV over 10 minutes
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity
Phase II Once the MTD is determined 58 additional patients are treated at that dose level as in phase I
Patients are followed at 6 weeks every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 78 patients 20 for phase I and 58 for phase II will be accrued for this study within 2 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 |
|---|---|---|---|
| NCI-V02-1691 | OTHER_GRANT | National Cancer Institute | None |
| CDR0000069211 | REGISTRY | None | None |