CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 196 target
Drug / intervention
Decitabine +2 moredrug
Likely dose
Decitabine 20mg/m2from 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/NCT04123392
NCT04123392Phase 3Unknown

Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Nanfang Hospital, Southern Medical University·interventional·Posted Oct 10, 2019·Updated Oct 10, 2019

In Brief

A Phase 3 clinical trial evaluating Decitabine, Busulfan (BU), and 1 other intervention for TP53 and 3 related conditions. Targeting 196 participants across 1 site.

Detailed Summary

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in TP53+ myeloid tumors undergoing allo-HSCT are evaluated.

Study Details

Timeline

Phase 3UnknownOverdue
2020202120222023202420252026
First PostedOct 10, 2019
Enrollment StartOct 1, 2019
Primary CompletionSep 1, 2022
Study CompletionSep 1, 2023
TodayJul 1, 2026
Enrollment to primary: 2.9 yearsPosted 6.7 years ago

Interventions

Decitabinedrug

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

Busulfan (BU)drug

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Cyclophosphamide (CY)drug

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