Status:
UNKNOWN
A Study of Improving the Efficacy of Treatment in Diffused Large B Cell Lymphoma Patients
Lead Sponsor:
Sun Yat-sen University
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18-70 years
Brief Summary
This is a prospective , open, multicenter, randomized phase Ⅲ study. The investigators planed to include 732 untreated CD20 positive diffused large B cell lymphoma adults,to random to R-CHOP21, CHOP14...
Detailed Description
This is a prospective , open, multicenter, randomized phase Ⅲ study. We planed to include 732 untreated CD20 positive diffused large B cell lymphoma adults,to random to R-CHOP21, CHOP14 , R-CHOP14 reg...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥18 and ≤70 years old.
- Histological documented untreated CD20(+) diffused large B cell lymphoma.
- Measurable disease and evaluable lesion.
- Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease.
- Normal Haematological,liver and kidney function (Neutrophil count ≥ 1.5 × 109/L ,hemoglobin ≥ 100g/L,platelets ≥ 100 × 109/L)
- ECOG Performance status 0-3,Life expectancy of at least 3 months.
- Without history of another malignancy
- Without any conflict serious systemic disease
- Without any accompany treatment(including steroids drugs)
- Subjects must have signed and informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Female subjects must be practicing and effective methods of birth control for at least 6 months throughout and after study; and have a negative serum β-hCG pregnancy test at screening.
- Exclusion Criteria
- Patients with prior clinical study within 3 months.
- Secondary lymphoma induced by chemotherapy or radiotherapy for another malignancy
- Transformed lymphoma
- Primary central nervous system lymphoma or primary testis lymphoma
- History of allergic reaction to any ectogenic proteins
- Prior treatment for lymphoma .
- History of another malignancy
- Neutrophil count \< 1.0× 109/L ,hemoglobin \< 90g/L,platelets \< 90 × 109/L,concurrent treatment with systemic antibiotic or antiviral drug for active infection.
- Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with depression of ST-T for electrocardiogram, myocardial infarction within 6 months
- Serious infective or organic disease
- Kidney dysfunction not related to lymphoma(Creatinine clearance≥ 2× institutional upper limit of normal)
- liver dysfunction not related to lymphoma(transaminase≥3× institutional upper limit of normal,and/or bilirubin≥2.0mg/dl)
- clinical syndrome of encephalon functional disorder,serious psychosis
- female subject who is pregnant or breast-feeding
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
732 Patients enrolled
Trial Details
Trial ID
NCT01793844
Start Date
January 1 2008
End Date
December 1 2017
Last Update
December 11 2015
Active Locations (1)
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1
Tumor center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060