CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 242 target
Drug / intervention
Granulocyte Colony-Stimulating Factor(G-CSF) +5 moredrug
Likely dose
Granulocyte Colony-Stimulating Factor(G-CSF) 20Gfrom 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/NCT05453552
NCT05453552Phase 3Unknown

G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With High-risk MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Nanfang Hospital, Southern Medical University·interventional·Posted Jul 12, 2022·Updated Mar 21, 2023

In Brief

A Phase 3 clinical trial evaluating Granulocyte Colony-Stimulating Factor(G-CSF), Decitabine (DAC), and 4 other interventions for Myelodysplastic Syndrome and 2 related conditions. Targeting 242 participants across 1 site.

Detailed Summary

Allo-HSCT is the most effective way to cure high-risk MDS patients. At present, the best conditioning regimen for high-risk MDS patients undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in high-risk MDS patients undergoing allo-HSCT are evaluated.

Study Details

Timeline

Phase 3UnknownOverdue
2023202420252026
First PostedJul 12, 2022
Enrollment StartJul 1, 2022
Primary CompletionDec 1, 2023
Study CompletionDec 1, 2024
TodayJul 1, 2026
Enrollment to primary: 1.4 yearsPosted 4.0 years ago

Interventions

Granulocyte Colony-Stimulating Factor(G-CSF)drug

G-CSF was administered at 5 ug/kg/day on days-17 to -10. When white blood cell is more than 20G/L, stop using G-CSF.

Decitabine (DAC)drug

Decitabine was administered at 20mg/m2/day on days -14 to -10.

Busulfandrug

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group.

Fludarabine (FLU)drug

Fludarabine was administered at 30 mg/m2/day on days -7 to -3.

Cyclophosphamide (CY)drug

Cyclophosphamide was administered at 60 mg/kg/day on days -3,-2.

Busulfan (BU)drug

Busulfan was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group.