CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 122 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/NCT03596892
NCT03596892Phase 3Unknown

Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Nanfang Hospital, Southern Medical University·interventional·Posted Jul 24, 2018·Updated Jul 24, 2018

In Brief

A Phase 3 clinical trial evaluating Decitabine, Busulfan (BU), and 1 other intervention for Allogeneic Hematopoietic Stem Cell Transplantation and 2 related conditions. Targeting 122 participants across 1 site.

Detailed Summary

Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. 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 MLL+ acute leukemia undergoing allo-HSCT are evaluated.

Study Details

Timeline

Phase 3UnknownOverdue
20192020202120222023202420252026
First PostedJul 24, 2018
Enrollment StartJul 1, 2018
Primary CompletionJun 1, 2021
Study CompletionJun 1, 2022
TodayJul 1, 2026
Enrollment to primary: 2.9 yearsPosted 7.9 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.