Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014664
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-04-10
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
PDL BioPharma Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Open-Label Randomized Multicenter Trial To Evaluate The Preliminary Safety And Efficacy of Hu1D10 In Patients With Relapsed Or Refractory Grades I II or III B-Cell Non-Hodgkins Lymphoma Including Follicular Small Lymphocytic And Marginal ZoneMALT
Status:
UNKNOWN
Status Verified Date:
2002-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 to them without harming normal cells
PURPOSE Randomized phase II trial to compare the effectiveness of two different monoclonal antibody regimens in treating patients who have relapsed or refractory non-Hodgkins lymphoma
PURPOSE Randomized phase II trial to compare the effectiveness of two different monoclonal antibody regimens in treating patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the relative safety of 3 different regimens of monoclonal antibody Hu1D10 in patients with relapsed or refractory grade I II or III B-cell non-Hodgkins lymphoma
Compare the preliminary tumor response and progression-free survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive monoclonal antibody MOAB Hu1D10 IV over approximately 2 hours on days 1 8 15 and 22
Arm II Patients receive MOAB Hu1D10 as in arm I at a higher dose
Arm IIIPatients receive MOAB Hu1D10 IV on days 1 3 5 8 10 12 15 17 19 22 24 and 26
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity
Patients are followed at weeks 1 4 and 12 and then at months 6 9 12 18 and 24
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Compare the relative safety of 3 different regimens of monoclonal antibody Hu1D10 in patients with relapsed or refractory grade I II or III B-cell non-Hodgkins lymphoma
Compare the preliminary tumor response and progression-free survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive monoclonal antibody MOAB Hu1D10 IV over approximately 2 hours on days 1 8 15 and 22
Arm II Patients receive MOAB Hu1D10 as in arm I at a higher dose
Arm IIIPatients receive MOAB Hu1D10 IV on days 1 3 5 8 10 12 15 17 19 22 24 and 26
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity
Patients are followed at weeks 1 4 and 12 and then at months 6 9 12 18 and 24
PROJECTED ACCRUAL A total of 60 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 |
|---|---|---|---|
| CUMC-0101-552 | None | None | None |
| PDL-1D10-901 | None | None | None |