Chemotherapy-Induced Neutropenia Clinical Trial
Official title:
A Phase 3 Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.
A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The
Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor
(rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid
Malignancies.
Adult patients (18 years of age or older) diagnosed as having any malignancy (except myeloid
malignancy, ECOG status of 0-2 and having a history of experiencing neutropenia (absolute
neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of
chemotherapy on the same drugs would be recruited into the study.
Treatment will be initiated not earlier than 24 hours after the administration of cytotoxic
chemotherapy in both groups.
Group 1: Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha)
- Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous
infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count
of 10,000/mm3 is reached whichever is earlier Group 2: Neupogen (rhG-CSF)
- Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion
for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of
10,000/mm3 is reached whichever is earlier Primary End Point would be to evaluate the
percentage of patients developing febrile neutropenia (defined as body temperature ≥
38.2°C or developing a temperature of > 38°C twice in a 12-hour period and absolute
neutrophil count < 0.5 x 109/L on the same day of the fever or the day after)in the two
treatment groups.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02643901 -
Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT02251977 -
Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer
|
Phase 3 | |
Terminated |
NCT02454530 -
Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
|
||
Active, not recruiting |
NCT02104830 -
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients
|
Phase 3 | |
Completed |
NCT04914702 -
Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
|
||
Active, not recruiting |
NCT03294577 -
Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia
|
Phase 3 | |
Not yet recruiting |
NCT03701841 -
Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis
|
||
Completed |
NCT03251768 -
Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients
|
Phase 2 | |
Recruiting |
NCT04101760 -
Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer
|
Phase 3 | |
Completed |
NCT04134429 -
Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy
|
||
Completed |
NCT04227990 -
Plinabulin iv Solution in Prevention of TAC Induced Neutropenia
|
Phase 2 | |
Completed |
NCT03102606 -
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3
|
Phase 3 | |
Completed |
NCT01569087 -
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients
|
Phase 2 | |
Completed |
NCT05512676 -
Trabectedin/Caelyx vs Cisplatin Hypersensitivity in Relapsed Ovarian Cancer Patients Allergic to Platinum
|
||
Completed |
NCT04460079 -
Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN
|
||
Recruiting |
NCT02725606 -
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer
|
Phase 1 | |
Completed |
NCT02692742 -
Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia
|
Phase 2 | |
Completed |
NCT02532712 -
Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01516736 -
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
|
Phase 3 | |
Terminated |
NCT04887831 -
Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab
|
Phase 2 |