Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma
|Diffuse Large B-cell Lymphoma||Drug: Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Yt90Zevalin Plus CHOP, Z-CHOP|
- 2-year progression-free survival and overall survival of patients
- Response rate (partial response, complete unconfirmed response, and complete response)in patients
- 2-year progression-free survival, overall survival and response rate in BCL-2 positive patients
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||January 2010|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkin's lymphoma. The radiobiological effects associated with Yt90-labelled ibritumomab tiuxetan (Zevalin) include the induction of apoptosis and cell-cycle redistribution.
The response rate tend to be higher in patients who have been treated with fewer prior therapies and Yt90-labelled ibritumomab tiuxetan may be suitable for use early in the course of therapy.
Yt90-labelled ibritumomab tiuxetan has less non hematologic toxicity than chemotherapy, with only minimal alopecia, mucositis, nausea, or vomiting, and a lower incidence of infections.
Yt90-labelled ibritumomab tiuxetan regimen is routinely and safely given in an outpatient setting and is completed in 7-9 days and is thus more convenient to be used.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386321
|King Chulalongkorn Memorial Hospital|
|Bangkok, Thailand, 10330|
|Principal Investigator:||Udomsak Bunworasate, M.D.||Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University|