CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 202 enrolled
Drug / intervention
Sorafenibdrug
Likely dose
Sorafenib 400 mgfrom 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/NCT02474290
NCT02474290Phase 3Completed
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Sorafenib for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3-ITD Positive Acute Myeloid Leukemia

Nanfang Hospital, Southern Medical University·interventional·Posted Jun 17, 2015·Updated Aug 26, 2019

In Brief

A Phase 3 clinical trial evaluating Sorafenib for Acute Myeloid Leukemia and Hematopoietic Stem Cell Transplantation. Completed, enrolled 202 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD positive acute myeloid leukemia (AML).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Hematopoietic Stem Cell Transplantation
CountriesChina
CollaboratorsPeking University People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital, Xiangya Hospital of Central South University, First People's Hospital of Chenzhou, The First Affiliated Hospital of Guangzhou Medical University

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 17, 2015
Enrollment StartJun 20, 2015
Primary CompletionJul 21, 2018
Study CompletionAug 10, 2019
TodayJul 1, 2026
Enrollment to primary: 3.1 yearsPosted 11.0 years ago

Interventions

Sorafenibdrug

The initial dose of sorafenib is 400 mg orally twice daily and is adjusted in case of suspected toxicity or resistance (dose range, 200-800 mg daily).