The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial remission after 6 cycles of CHOP therapy.

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

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed, CD 20 positive diffuse large B-cell lymphoma, meeting 1 of the following stage criteria: Bulky stage II disease, Stage III disease, Stage IV disease at the initial diagnosis.

• Bidimensionally measurable disease

• Age 18 - 75 Years

• Performance status Zubrod 0-2

• Less than 20,000/mcL circulating lymphoid cells on WBC differential count

• Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original diagnostic specimen available

• Needle aspiration or cytology are not considered adequate

• No clinical evidence of CNS involvement by lymphoma

• No prior diagnosis of indolent lymphoma

• No histologic transformation

• Life expectancy : Not specified

• Hepatic : Not specified

• Renal : Not specified

• Cardiovascular

• Ejection fraction ≥ 45% by MUGA OR

• No significant abnormalities by echocardiogram

• Pulmonary : No requirement for continuous supplemental oxygen

• Other

• All adult patients of reproductive potential must use contraception during and for 6 months after completion of study treatment

• No other malignancy within the 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 the cervix

• No known HIV positive

• Written informed consent

• PRIOR CONCURRENT THERAPY:

• Biologic therapy : No prior antibody therapy for lymphoma

• Chemotherapy : 6 cycles of CHOP

• Endocrine therapy : Not specified

• Radiotherapy : No prior radiotherapy for lymphoma

• Surgery : No prior solid organ transplantation

Exclusion Criteria:

• Previous antineoplastic treatment other than the 6 cycles of CHOP for the initial treatment of DLBCL

• Positive HIV serology

• Positive serology of HCV with the presence of HCV RNA of chronic hepatitis

• Positive serology of HBV with the presence of HBV RNA of chronic hepatitis

• Serum creatinine or bilirubin > 2.5 x upper limit of normal

• Active uncontrolled infection

• Concurrent severe and/or uncontrolled medical disease which could compromise the participation in the study

• Patients in whom more than 25% of the bone marrow has been infiltrated by lymphoma cells

• Patients with platelet counts <100,000/µl or neutrophil counts < 1500/µl