Trials / Completed
CompletedNCT04788420
Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allo-HSCT for Patients With FLT3-ITD AML
Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for Patients With FLT3-ITD Positive Acute Myeloid Leukemia
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 456 (actual)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to reveal the influence of co-existing mutations on the efficacy of sorafenib maintenance after allogeneic hematopoietic stem cell transplantation for patients with FLT3-ITD AML.
Detailed description
Internal tandem duplication of FMS-like tyrosine kinase 3 (FLT3-ITD) mutations have been reported in 20%-30% of patients with acute myeloid leukemia (AML). FLT3-ITD-positive AML patients have an inferior survival, primarily due to lower complete remission (CR) rate and higher relapse rate. Our previous studies demonstrated that post-transplantation sorafenib maintenance could improve the outcomes of FLT3-ITD-positive AML patients. However, whether other co-existing mutations influence the efficacy of post-allo-HSCT sorafenib maintenance remains unknown.
Conditions
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia With FLT3/ITD Mutation
- Hematopoietic Stem Cell Transplantation
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib | 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). |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2018-07-21
- Completion
- 2020-12-31
- First posted
- 2021-03-09
- Last updated
- 2022-06-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04788420. Inclusion in this directory is not an endorsement.