Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078598
Status:
UNKNOWN
Last Update Posted:
2005-11-09
First Post:
2004-03-01
Brief Title:
A Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Non-Hodgkins Lymphoma
Sponsor:
Corixa Corporation
Organization:
Corixa Corporation
Study Overview
Official Title:
A Multi-Center Randomized Phase III Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Relapsed Follicular Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2004-10
Last Known Status:
RECRUITING
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:
A total of 506 patients 253 per arm will be enrolled at 30 to 40 sites in the United States and Europe
Patients will be randomly assigned to one of two treatment arms In Arm A patients will receive 375 mgm2 of rituximab US Canada - Rituxan EU - Mabthera given as an IV infusion once weekly for 4 weeks In Arm B patients will receive Iodine I 131 Tositumomab therapy For Arm B patients undergo a two-phase treatment In the first phase termed the dosimetric dose patients will receive an infusion of unlabeled Tositumomab 450 mg immediately followed by an infusion of Tositumomab 35 mg that has been labeled with 5 mCi 018 GBq of iodine 131 Whole body gamma camera scans will be obtained three times Day 0 Day 2 3 or 4 and Day 6 or 7 following the dosimetric dose Using the dosimetric data from these three imaging timepoints the patients weight and platelet count a patient-specific administered activity of iodine I 131 Tositumomab expressed in mCi or GBq will be calculated to deliver the desired total body dose of radiation 65 or 75 cGy In the second phase termed the therapeutic dose patients in Arm B will receive an infusion of unlabeled Tositumomab 450 mg immediately followed by an infusion of the patient-specific administered activity of Iodine 131-conjugated Tositumomab 35 mg
Patients on study will be followed for response and safety at Week 7 Week 13 and every 3 months for the first and second years every 6 months for the third year and then annually for the fourth and fifth years Patients will be followed for safety only annually for years 6-10
Patients will be randomly assigned to one of two treatment arms In Arm A patients will receive 375 mgm2 of rituximab US Canada - Rituxan EU - Mabthera given as an IV infusion once weekly for 4 weeks In Arm B patients will receive Iodine I 131 Tositumomab therapy For Arm B patients undergo a two-phase treatment In the first phase termed the dosimetric dose patients will receive an infusion of unlabeled Tositumomab 450 mg immediately followed by an infusion of Tositumomab 35 mg that has been labeled with 5 mCi 018 GBq of iodine 131 Whole body gamma camera scans will be obtained three times Day 0 Day 2 3 or 4 and Day 6 or 7 following the dosimetric dose Using the dosimetric data from these three imaging timepoints the patients weight and platelet count a patient-specific administered activity of iodine I 131 Tositumomab expressed in mCi or GBq will be calculated to deliver the desired total body dose of radiation 65 or 75 cGy In the second phase termed the therapeutic dose patients in Arm B will receive an infusion of unlabeled Tositumomab 450 mg immediately followed by an infusion of the patient-specific administered activity of Iodine 131-conjugated Tositumomab 35 mg
Patients on study will be followed for response and safety at Week 7 Week 13 and every 3 months for the first and second years every 6 months for the third year and then annually for the fourth and fifth years Patients will be followed for safety only annually for years 6-10
Detailed Description:
None
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