Prospective, multi-centric, open label, two arm, parallel group, active control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-029/ NeulastaÂ® (NeulastimÂ®) when given subcutaneously in patients with Chemotherapy Induced Neutropenia.

Reliance Life Sciences Pvt Ltd0 个研究点目标入组 105 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Adult patients of either sex in the age group of 18 to 65 years
•2.Patients scheduled to receive myelosuppressive chemotherapy regimens.
•3.Any previous chemotherapy exposure should have been completed >3 weeks before randomization and no more than 1 cycle of chemotherapy for the existing disease is allowed before randomization into the present study.
•4.Patients with high risk or intermediate risk of developing chemotherapy-induced febrile neutropenia as per NCCN guidelines.
•5.Patients planned and eligible to undergo at least 4 cycles of chemotherapy after randomization.
•6.Eastern Cooperative Oncology Group (ECOG) performance status <=2.
•7.Adequate hematologic function
•8.Estimated life expectancy >6 months
•9.Females of childbearing potential should be willing to use an approved method of contraception.
•10.Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.

•1.Known active acute or chronic infection
•2.Pregnant or breastfeeding women, and women not practicing effective contraception.
•3.Known hypersensitivity to the active ingredient or other product constituents.
•4.Patients with history of radiation within 4 weeks before the first cycle of chemotherapy in the study
•5.Patient is on bleomycin- or carbazitaxel-containing chemotherapy regimen
•6.Patient with body weight 45 kg
•7.Previous bone marrow or stem-cell transplantation
•8.Diagnosis of concurrent second malignancy
•9.Serious inter-current chronic or acute illness
•10.Systemic autoimmune disorder and/or chronic use of immunosuppressive agents during the 6 weeks prior to the first cycle of chemotherapy in the study
•11.History of chemotherapy causing delayed myelosuppression
•12.Concurrent use of other granulocyte colony stimulating growth factors
•13.Received prophylactic antibiotics within the preceding 6 weeks.
•14.Patients with neuropathy of grade 2 or higher.
•15.Impaired renal or hepatic function.
•16.Any other medical condition, which in opinion of the investigator, may affect patientâ??s participation in the study
•17.Patientâ??s participation in another clinical trial 90 days prior to administration of IP.

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