Status:
COMPLETED
The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP
Lead Sponsor:
Mahidol 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 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 cycl...
Detailed Description
Diffuse large B-cell lymphomas (DLBCL) are the most common lymphoid neoplasm and account for 30% to 40% of adult non-Hodgkin lymphomas (NHL). DLCBL is a potentially curable disease. The ultimate goals...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00440583
Start Date
September 1 2006
End Date
May 1 2012
Last Update
January 30 2015
Active Locations (1)
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1
Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700