comparing Biosimilar Rituximab (RTXM83) Plus CHOP Chemotherapy Versus a Reference Rituximab Plus CHOP (R-CHOP) in patients with Diffuse large B-cell lymphoma (DLBCL) given as first line
- Conditions
- diffuse large B-cell lymphom.diffuse large B-cell lymphom
- Registration Number
- IRCT2014121612398N5
- Lead Sponsor
- Actoverco Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 250
1. Patients with measurable disease defined as existence of a unidimensional or bidimensional lesion greater than 2 cm in its longest diameter or malignant lymphocytosis greater than 5x109/L. Any other procedure for measurable disease in particular cases, may be allowed upon Sponsor approval.
2. Newly diagnosed patients with a confirmed pathologic diagnosis of large B cell-non-Hodgkin’s lymphoma (DLBCL) with untreated CD20+. Defined by the local Haematopathologist at the local laboratory according to WHO criteria. 3. Stage II-III or IV or stage I with bulk defined by the referring physician on the basis of the Cotswolds modification of the Ann Arbor classification.2
4. Age-adjusted International Prognostic Index (IPI) score 0 or 1.
5. Age =18 to =65 years of age.
6. Performance status (Eastern Cooperative Oncology Group [ECOG]) of =2.
7. Written informed consent obtained before starting any study-specific procedure.
8. Females of child-bearing potential must test negative on standard serum pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the study (e.g. oral contraceptive, double barrier method, intra-uterine device, intra-muscular contraceptive).
9. All male patients must take adequate contraceptive precautions during the course of the study.
Exclusion criteria:
1. Life expectancy of less than three months.
2. Any other lymphoma other than CD20+ DLBCL.
3. Indolent lymphoma, Primary central nervous system (CNS) Lymphoma or gastro-intestinal Mucosa Associated Lymphoid Tissue (MALT) Lymphoma.
4. Known hypersensitivity to active ingredients, excipients and murine and foreign proteins.
5. Concurrent disease or general status that would exclude giving the treatment as outlined in the protocol.
6. Active uncontrolled infection requiring systemic treatment with antibiotics or antiviral agents at Screening or history of documented recurrent clinically significant infection (e.g. 2 or more viral, bacterial or fungal infections requiring inpatient treatment).
7. Cardiac contra-indication to Doxorubicin therapy: non-compensated heart failure, dilated cardiomyopathy, coronary heart disease with ST segment depression on electrocardiogram (ECG), myocardial infarction in the last 6 months.
8. Neurologic contra-indication to Vincristine as it is indicated in the SmPC: (e.g. peripheral neuropathy).
9. Chronic lung disease with hypoxemia measured by saturometer (gasometry is not mandatory).
10. Severe uncontrolled hypertension, despite optimal medical treatment.
11. Severe uncontrolled diabetes mellitus, despite optimal medical treatment.
12. Renal insufficiency (Serum Creatinine>2xUNL).
13. Hepatic insufficiency (aspartate aminotransferase [AST]/alanine aminotransferase [ALT] >3xUNL or >5xUNL with involvement of the liver, total bilirubin >34.2 µmol/L, or both) not related to lymphoma.
14. Clinical signs of cerebral dysfunction.
15. Severe psychiatric disease. 16. Known human immunodeficiency virus (HIV) infection or active chronic hepatitis B or C.
17. Abnormal bone marrow function (platelets <100x109/L, neutrophils <1.5x109/L and Hemoglobin <9g/dL).
18. Post-transplantation lymphoproliferative disease.
19. Pregnant or lactating women or women that intend to get pregnant during study or within 12 months following the last infusion.
20. Treatment with any investigational product in the 30 days period before inclusion in the study.
21. Prior radiotherapy to
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate (RR). Timepoint: at the end of treatment (6 cycle of chemotherapy). Method of measurement: IWG criteria.
- Secondary Outcome Measures
Name Time Method EFS = time to progressive disease under therapy. Timepoint: every three months after last dose of chemotherapy and until 9 months. Method of measurement: IWG criteria.;Adverse Events. Timepoint: day 1, 8, 15 after each cycle of chemotherapy and 30 days after the end of study treatment. Method of measurement: graded according to the NCI-CTC criteria [v 4.0].