CTRI/2012/11/003129CompletedNot Applicable
A Randomised, Multi-centre, Double-blind, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Two Anti-CD20 Monoclonal Antibodies in Combination with CHOP in Patients with CD20-Positive Diffuse Large B-cell Lymphoma
Dr Reddys Laboratories Ltd36 sites in 1 country190 target enrollmentStarted: November 21, 2012Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dr Reddys Laboratories Ltd
- Enrollment
- 190
- Locations
- 36
- Primary Endpoint
- To evaluate the PK equivalence of two anti CD-20 antibodies [DRL-rituximab(Reditux™)and MabThera®]
Study Overview
Brief Summary
This study is a multi-centre, double-blind, parallel group, randomised comparative study of the pharmacokinetics,pharmacodynamics, safety and efficacy ofDRL-rituximab (Reditux™)and MabThera®. All study patients will also be administered cyclical combination chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone [CHOP]) which represents the standard of care for the disease condition. The disease condition will be monitored at standard intervals and patients requiring alternative therapy for any reason will be promptly removed from the study.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
To evaluate the PK equivalence of two anti CD-20 antibodies [DRL-rituximab(Reditux™)and MabThera®]
Time Frame: 3 weeks
Secondary Outcomes
- To assess the objective response rate (ORR) at 6 cycles as defined by Revised Response Criteria for Malignant Lymphoma (Cheson, 2007)(18 weeks)
Investigators
Study Sites (36)
Loading locations...
Similar Trials
Completed
Not Applicable
A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent CatheterisationUrinary CatheterizationNCT00753298Wellspect HealthCare195
Unknown
Phase 4
Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination TherapyPerennial Allergic RhinitisNCT01062139HK inno.N Corporation100
Completed
Phase 3
Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic ArthritisPsoriatic ArthritisNCT05046431Bio-Thera Solutions704
Terminated
Phase 1
A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid ArthritisArthritis, RheumatoidRheumatoid ArthritisNCT03161457JHL Biotech, Inc.153
Completed
Phase 2
Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of MigraineAcute MigraineNCT02745392Zosano Pharma Corporation365