None listed
Conditions
Interventions
Intervention1: Rituximab: 375mg/m2 for 4 to 8 weeks at an interval of 1 to 3 weeks depending upon the indication and stage of the disease
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Zenotech Laboratories limited,8-2-120 /112 /88-89, Park View Estate, 4th Floor, Road No. 2, Banjara Hills, Hyderabad. Tel: +91 40 2354 0994
Fax: +91 40 2355 5465
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Subjects must meet all of the following criteria to be included: 1.Subject has signed and dated informed consent document. 2.Subjects aged 18 years and above with one of the following diagnosis. A. Relapsed or refractory low grade or follicular B-cell Lymphoma (International Working Formulation [IWF types A-D]-Rituximab naïve. OR B. Previously untreated, FoIlicular, B-cell NHL (Rituximab in combination with CVP therapy) [IWF B-D]. OR C.Previously untreated, Diffuse large B-cell NHL (Rituximab in combination with CHOP therapy) [IWF G]. 3.CD20 positive tumor. 4.Subject should have at least one measurable lesion (lesion size > 1cm × 1 cm) on CT scan. 5.Subjects with stage I to IV disease according to Modified Ann Arbor criteria. 6.Subjects with a performance status of 0-2 according to the Eastern Cooperative Oncology Group (ECOG). 7.Subjects expected to have a survival of 6 months or more (as per judgment of investigator). 8.At least four weeks have been passed from the last dose of the previous therapy and subject should have recovered from the significant toxicities of the prior therapy (as per the discretion of investigator).
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1.Subjects with history of T-cell Lymphoma. 2.Subjects with known history of anaphylaxis or hypersensitivity to murine proteins or to any component of the investigational product. 3.Subjects with CNS involvement or CNS lymphoma. 4.Subjects with reduced renal function: creatinine level greater than 2 times of the upper normal limit (ULN), compromised liver function: total bilirubin level greater than 2.5 mg/dL (>1.2 mg/dL in subjects diagnosed with diffuse large B cell lymphoma), AST/SGOT, ALT/SGPT or alkaline phosphatase level more than 3 times ULN), inadequate bone marrow reserve: hemoglobin concentration less than 8 g/dL, platelets  75000 cells/mm3 and ANC 1500 cells/mm3. 5.Subjects positive for HIV or hepatitis B or hepatitis C antigens. 6.Subjects with history of malignancy or concomitant malignancy (other than the study disease). 7.Subjects with history of clinically significant renal, hepatic, cardiovascular, haematologic (except the disease in consideration), endocrine, pulmonary, gastrointestinal, urogenital, psychiatric illness or severe mental retardation and progressive neurologic disease which in the opinion of the investigator may jeopardize the safety of the subject during the study or may interfere with the evaluation of efficacy of the study medication. 8.Subjects previously enrolled in this study. 9.Pregnant or breast-feeding women or women with positive urine pregnancy test at screening. 10.Subjects who are unable or unwilling to comply with the study procedures. 11.Subjects who have participated in another investigational study within the last 3 months prior to entry in this study. Disease specific exclusion criteria A. Relapsed or refractory low grade or follicular Non Hodgkin?s Lymphoma (Rituximab naïve) 1.Subjects who have received prior therapy with Rituximab 2.Subjects with history of more than four relapses following first therapy B.Previously Untreated, FoIlicular CD 20-Positive, B-cell NHL 1.Subjects who have received any prior therapy for FoIlicular B-cell NHL. 2.Subjects with known history of anaphylaxis or hypersensitivity to cyclophosphamide, vincristine or prednisolone. 3.Subjects with history of clinically significant urine retention or significant bladder disease. 4.Subjects with history of epilepsy. 5.Subjects with history of demyelinating form of charcot-Marie-Tooth syndrome, significant peripheral neuropathies or any other disease of neuromuscular origin. 6.Concomitant use of succinyl choline, general anesthesia. C.Previously Untreated, Diffuse Large B-Cell NHL 1.Subjects with known history of anaphylaxis or hypersensitivity to cyclophosphamide, vincristine, doxorubicin or prednisolone. 2.Subjects who have received any prior therapy for Diffuse large B-Cell NHL. 3.Subjects with history of clinically significant cardiac disease e.g., CHF, myocarditis, pericarditis or evidence of deterioration of cardiac function by ECHO cardiography (Left Ventricular Ejection Fraction (LVEF)  45%). 4.Subjects with history of significant urine retention or significant bladder disease. 5.Subjects with history of epilepsy. 6.Subjects with history of demyelinating form of charcot-Marie-Tooth syndrome or significant peripheral neuropathies. 7.Concomitant use of verapamil, succinyl choline, general anesthesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) ORR is defined as the proportion of subjects with tumor size reduction of a predefined amount and for a minimum time period. It is measured as the sum of partial responses and complete responses (CR+PR).Timepoint: Responses would be assessed at the End of Study (EOS): It would be classified as Objective Responders (complete response + partial response), stable disease, or progressive disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) PFS will be assessed at both the follow up visits. All objective responders will be followed up for 6 months after end of study visit and will be reported as all cause deaths, progression free subjects and subjects with symptomatic and/or laboratory and/or radiological deterioration. Subjects with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time should be reported as ?symptomatic deterioration?. Every effort should be made to document the objective progression even after discontinuation of treatment.Timepoint: Follow Up visit 1 (3 months after End of Study Visit) and Follow Up visit 2 (6 months after End of Study Visit) | — |
Countries
India
Contacts
Public ContactKanchan Tyagi
Outcome results
None listed