Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00386321|
Recruitment Status : Terminated (Participants are no longer being examined or treated.)
First Posted : October 11, 2006
Last Update Posted : November 18, 2010
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma||Drug: Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Yt90Zevalin Plus CHOP, Z-CHOP|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||July 2007|
|Estimated Study Completion Date :||January 2010|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|