Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma
The purpose of this study is to determine whether the treatment of Yt90 Zevalin in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)are effective as first line treatment in patients with bulky stage II or stage III or IV diffuse large B-cell lymphoma
Diffuse Large B-cell Lymphoma
Drug: Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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.
|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|