Clinical Trial: Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Saftey and Efficacy Phase II Study of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

Brief Summary: This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.

Detailed Summary:

The study consist of a screening period and a 21-day chemotherapy period of the same chemotherapy treatment cycle(s).Screening the subjects according to the inclusion criteria and exclusion criteria before 2 weeks of chemotherapy, and the screening successfully patients will be eligible for this study. The 1st chemotherapy treatment cycle defined as subjects screening period, subjects will be treated with the TC or EC regimen on the 1st day, aiming to screen out Chemotherapy-induced Neutropenia of ≥grade 3 (ANC＜1.0×10^9/L) who can have the eligible to enter the 2nd chemotherapy treatment cycle, otherwise to quit the study. On the 1st day in cycle 2, subjects will be treated with the same regimen as the 1st chemotherapy treatment cycle, and be received the test drugs or controlled from the 3rd day to observe the efficacy and safety.

【Primary Outcome Measures】:

• Duration of ≥grade 3 neutropenia in cycle 2

【Secondary Outcome Measures】:

  • Incidence of ≥grade 3 neutropenia induce;
  • Incidence of febrile neutropenia;
  • Duration for ANC from chemotherapy finished to ANC nadir and the minimum ANC ;
  • Duration for ANC recovery from nadir to 2.0×10^9/L.

Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Current Primary Outcome: Duration of ≥grade 3 neutropenia in cycle 2 [ Time Frame: 21 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: change of Neutropenia and ANC in cycle 2 [ Time Frame: 21 days ]

  1. Incidence of ≥grade 3 neutropenia;
  2. Incidence of febrile neutropenia;
  3. Measurement the duration from chemotherapy finished to the ANC reached the nadir and the value of ANC`s nadir;
  4. Time to ANC recovery,the time from chemotherapy administration until the patient`s ANC increasd to 2.0*109/L after the expected nadir


Original Secondary Outcome: Same as current

Information By: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Dates:
Date Received: August 6, 2013
Date Started: July 2013
Date Completion:
Last Updated: November 9, 2015
Last Verified: November 2015