Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268983
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2005-12-21
Brief Title:
Comparison Of Rituximab Versus Tositumomab and Iodine I 131 Tositumomab BEXXAR Therapeutic Regimen For Patients With Relapsed Follicular Non-Hodgkins Lymphoma
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multi-Center Randomized Phase 3 Study of Rituximab Versus Iodine I 131 Tositumomab Therapeutic Regimen For Patients With Relapsed Follicular Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-11
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:
Comparison of rituximab versus Iodine I 131 Tositumomab Therapeutic Regimen Tositumomab and Iodine I 131 Tositumomab or the Bexxar Therapeutic Regimen formerly called Iodine-131 Anti-B1 Antibody in subjects with follicular non Hodgkins B cell lymphoma 506 subjects will be enrolled at 30 to 40 sites in the US Canada and Europe Subjects will be randomly assigned to one of two treatment arms In Arm A subjects will receive 375 milligramsmeter2 mgm2 of rituximab given as an intravenous IV infusion once weekly for 4 weeks In Arm B subjects will undergo a two-phase treatment In the first phase termed the dosimetric dose subjects will receive an infusion of unlabeled Tositumomab 450 mg immediately followed by an infusion of 5 millicuries mCi 018 gigabecquerel GBq of Iodine 131 Tositumomab 35 mg 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 The information derived from the scans will enable a patient specific dose to be calculated to deliver the desired total body dose of radiation 65 or 75 centigray cGy In the second phase termed the therapeutic dose subjects in Arm B will receive an infusion of unlabeled Tositumomab 450 mg immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated Tositumomab 35 mg Thyroid blockade will be implemented 24 hours prior to the dosimetric dose and continued for 14 days following the therapeutic dose Subjects on study will be followed for response and safety at Week 7 Week 13 and every three months for the first and second year every six months for the third year and then annually for the forth and fifth years and then for vital status additional therapy and long term safety events through year ten Follow Up after subsequent NHL therapy will be carried out to assess tolerance of next anti-lymphoma therapy development of myelodysplasia MDSacute myelogenous leukemia AML HAMA or hypothyroidism unexpected safety issues and death
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