Status:
TERMINATED
Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma
Lead Sponsor:
Chulalongkorn University
Collaborating Sponsors:
Bayer
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 treat...
Detailed Description
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-labe...
Eligibility Criteria
Inclusion
- Histologically confirmed CD20 positive diffuse large B-cell lymphoma with bulky stage II or stage III or stage IV
- Bidimensionally measurable disease
- Performance status Zubrod 0-2
- Less than 20,000/mcL circulating lymphoid cells on WBC differential count
- No clinical evidence of CNS involvement, no prior diagnosis of indolent lymphoma, no histologic transformation
- Ejection fraction more than or equal to 45% by MUGA or no significant abnormality by echocardiogram
- Fertile patients with effective contraception method
- No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma in situ of cervix
- No HIV positive, no prior solid organ transplantation
- No prior antibody therapy, chemotherapy, radiotherapy for lymphoma
Exclusion
- Serum creatinine ot bilirubin more than 2.5 X ULN unless due to lymphoma
- Active uncontrolled infection
- Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
- Patients with more than 25% infiltrated bone marrow
- Patients with platelet counts less than 100,000/mcL or neutrophil counts less than 1,500/mcL
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00386321
Start Date
April 1 2006
End Date
January 1 2010
Last Update
November 18 2010
Active Locations (1)
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1
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330