Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022945
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-08-16
Brief Title:
Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma
Sponsor:
Corixa Corporation
Organization:
Corixa Corporation
Study Overview
Official Title:
Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody followed by CHOP and to see what effects it has on patients with previously untreated mantel cell lymphoma
Detailed Description:
The primary efficacy endpoint of this study is to determine the duration of response of the sequential administration of Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP for patients with previously untreated MCL The secondary efficacy endpoints for this study are to determine the response rate confirmed response rate complete response rate confirmed complete response rate duration of response for confirmed responders duration of response for complete responders duration of response for confirmed complete responders progression-free survival time to treatment failure and the predictive value of detection of minimal residual disease by molecular techniques on response duration The pharmacokinetic endpoint is to determine the total body residence time of Iodine-131 Anti-B1 Antibody following the dosimetric dose The safety endpoints are to determine the incidence of adverse experiences hematologic toxicity eg nadir time to nadir and time to recovery use of supportive care percent of patients converting to human anti-murine antibody HAMA positivity the effects of Iodine-131 Anti-B1 Antibody on the growth and function of hematopoietic progenitor cells and survival of patients with previously untreated MCL treated with Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP
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