Health Condition 1: null- Diffuse LargeB-cellLymphoma
Conditions
Interventions
Intervention1: DRL-rituximab (Redituxâ?¢)(500 mg and 100 mg)
: Dose: 375 mg/m2, Frequency duration: 6 cycles with CHOP (each cycle of 21 days duration), Route of Administration: Intravenous infusion
C
Sponsors
Dr Reddys Laboratories Ltd
Quintiles
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients 18 to 60 years of age (both inclusive), with histologically confirmed CD20+ diffuse large B-cell lymphoma. 2. Eastern Cooperative Oncology Group (ECOG, also referred to as Zubrod) performance status of 0, 1, or 2 3. Stage II, III, or IV by the Ann Arborclassification (Cotswold modification) 4. Adequate liver and renal function 5. Ability to comply with all study requirements 6. Signed and dated informed consent
Exclusion criteria
Exclusion criteria: 1. Diffuse large B-cell lymphoma that is primary CNS, effusional, or intravascular according to the WHO, 2008 classification 2. Diffuse lymphoma for which CHOP is not adequate therapy 3. Bulky Disease 4. Any CNS involvement by lymphoma 5. Severe active infection 6. Pregnant or lactating women or women trying to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the PK equivalence of two anti CD-20 antibodies [DRL-rituximab(Redituxâ?¢)and MabThera®]Timepoint: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the objective response rate (ORR) at 6 cycles as defined by Revised Response Criteria for Malignant Lymphoma (Cheson, 2007)Timepoint: 18 weeks | — |
Countries
India
Contacts
Public ContactDevas Seth
Quintiles Research (India) Pvt. Ltd.
Outcome results
None listed