Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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 treatment in patients with bulky stage II or stage III or IV diffuse large B-cell lymphoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chulalongkorn University
• Collaborator: Bayer
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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