Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

398

Participants

Timeline

Start Date

October 16, 2020

Primary Completion Date

June 24, 2021

Study Completion Date

September 1, 2021

Conditions
Non-Myeloid Malignancy
Interventions
DRUG

YPEG-rhG-CSF

YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.

DRUG

YPEG-rhG-CSF

YPEG-rhG-CSF 33μg/kg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.

DRUG

rhG-CSF/PEG-rhG-CSF

rhG-CSF 5μg/kg/day, s.c. from day 3 to day 14 or until neutrophils recover to exceed 5.0×10\^9 cells/L, whichever comes first, in the first cycle. Patient can still continue rhG-CSF 5μg/kg/day, or covert to PEG-rhG-CSF 6mg/Cycle in the following 2-4 cycle. 21 day one cycles.

Trial Locations (1)

Unknown

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

lead

Xiamen Amoytop Biotech Co., Ltd.

INDUSTRY

NCT04466137 - Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy | Biotech Hunter | Biotech Hunter