A Phase IV Multi-Centric Post-Marketing Study Evaluating the Safety, Immunogenicity and EFFICACY of the Marketed Formulation of Hetero - Rituximab

Hetero Drugs Limited0 个研究点目标入组 200 人开始时间: 待定最近更新: 2023年12月19日

试验速览

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•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 <1.5 times ULN or total bilirubin =1.5 mg/dl, or total bilirubin =3 mg/dl for patients with Gilbert’s syndrome
•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%

•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

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