Health Condition 1: C911- Chronic lymphocytic leukemia of B-cell type Health Condition 2: M317- Microscopic polyangiitis Health Condition 3: C859- Non-Hodgkin lymphoma, unspecified Health Condition 4: null- Non-Hodgkins lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Granulomatosis with polyangiitis (Wegener’s granulomatosis) and Microscopic polyangiitis Health Condition 5: M069- Rheumatoid arthritis, unspecified Health Condition 6: M313- Wegeners granulomatosis
Conditions
Interventions
Intervention1: Rituximab: 100 mg/10 mL and 500 mg/50 mL solution in a single use
vial.: Recommended Dose for Non-Hodgkins Lymphoma (NHL)is 375 mg/m2 as an intravenous infusion for 8 cycles
Recommended
Sponsors
Hetero Drugs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures 2. Male and female adult patients, 18 years or older. 3. Patients with the following indications o Patients with diagnosed Non-Hodgkin’s lymphoma o Patients with diagnosed Chronic Lymphocytic Leukemia (CLL) o Patients with diagnosed Rheumatoid arthritis 4. Any other patients indicated Rituximab as per physician’s discretion according to the prescribing information. 5. Adequate liver, renal, cardiac and haematological function as evidenced by: o Transaminase (alanine transaminase [ALT]/aspartate transaminase [AST]) less than 2x upper limit of normal, or less than 5x upper limit of normal for patients with liver involvement o Bilirubin o Absolute Neutrophil count =1500/mm o Platelet count =100,000/mm o Serum Creatinine less than 1.5x upper limit of normal o Left ventricular ejection fraction (LVEF) =50%
Exclusion criteria
Exclusion criteria: 1. Patients with clinical history/ evidence of allergy/hypersensitivity to murine proteins or components of Hetero-Rituximab. 2. An active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections). 3. Major surgery within 4 weeks of study start 4. Need for emergency therapy such as neurologic compression syndrome 5. Receipt of live vaccine within 4 weeks prior to study drug administration 6. Current medical history/clinical evidence of hepatitis B or hepatitis C infection or HIV 7. Patients who are likely to be pregnant or lactating patients 8. Patients with history or pre-existing clinical evidence of medically significant abnormality or requirements for surgery that precludes the usage of Hetero-Rituximab, as per investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity, outcome, duration, action taken, and causality of individual adverse events [Expected and Unexpected adverse events (Serious and Non-serious Adverse Events)] reported during the studyTimepoint: All visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy- Change in efficacyTimepoint: at end of 6-8 cycles;Immunogenicity - development and change in antidrug antibodies (ADA) titer against Hetero – RituximabTimepoint: Screening, 6-8 cycles and 12 months | — |
Countries
India
Contacts
Public ContactDr S D Sinha
Hetero Drugs Limited
Outcome results
None listed