Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.
NCT06328179 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2024-03-25
Summary
This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA(Venetoclax with Homoharringtonine,Etoposide,Cytarabine)regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities.
This study includes the induction and consolidation phases of AML treatment.
Conditions
Interventions
- DRUG
-
Venetoclax 100 mg d1,200 mg d2,400 mg d3-14;
VHEA -Induction Phase Regimen/Consolidation therapy after remission
Sponsors & Collaborators
-
Zhenjiang First People's Hospital
collaborator OTHER -
The First People's Hospital of Changzhou
collaborator OTHER -
The Affiliated Hospital of Xuzhou Medical University
collaborator OTHER -
Huai'an First People's Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-24
- Primary Completion
- 2027-12-30
- Completion
- 2027-12-30
Countries
- China
Study Locations
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