CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 206 enrolled
Drug / intervention
rhGM-CSF group +2 moredrug
Likely dose
rhGM-CSF group 7μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01232504
NCT01232504Phase 4Completed
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Effect of Granulocyte-macrophage Stimulating Factor on Prevention and Treatment of Invasive Fungal Diseases in the Recipients of Allogeneic Stem Cell Transplantation: A Prospective Multicenter Randomized Phase 4 Trial

Xiamen Amoytop Biotech Co., Ltd.·interventional·Posted Nov 2, 2010·Updated Nov 4, 2014

In Brief

A Phase 4 clinical trial evaluating rhGM-CSF group, rhG-CSF+rhGM-CSF group, and 1 other intervention for Mycoses. Completed, enrolled 206 participants across 5 sites.

Detailed Summary

We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMycoses
CountriesChina
CollaboratorsShanghai Jiao Tong University Affiliated First People's Hospital

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2010
Enrollment StartSep 1, 2009
Primary CompletionMar 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.7 years ago

Interventions

rhGM-CSF groupdrug

subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days).

rhG-CSF+rhGM-CSF groupdrug

a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days).

rhG-CSF groupdrug

subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days).