Trials / Completed
CompletedNCT05456048
Influence of Molecular Abnormalities on Response of VAH vs. VEN+HMA in RR-AML
Influence of Molecular Abnormalities on Treatment Response of the Regimen of Venetoclax Plus Azacytidine Combined With Homoharringtonine Versus Venetoclax Plus Hypomethylating Agents (HMA) in Relapsed/Refractory Acute Myeloid Leukemia
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 231 (actual)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the salvage therapy of RR-AML.
Detailed description
Venetoclax-based regimens have heen used in the salvage therapy of relapsed/resfractory (RR) acute myeloid leukemia (AML). More and more studies have shown that molecular abnormalities and venetoclax combined regimens significantly impact the response of venetoclax-based therapy. Our exploratory study revealed that venetoclax plus azacytidine combined with homoharringtonine (VAH) had remarkably higher response than venetoclax plus hypomethylating agents (HMA) in RR-AML. Yet the influence of molecular abnormalities on the response of VAH regimen remains unknown.
Conditions
- Relapsed Acute Myeloid Leukemia
- Refractory Acute Myeloid Leukemia
- Gene Abnormality
- Cytogenetic Abnormality
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VAH regimen | VEN was prescribed as 100mg day 1, 200mg day 2, 400mg day 3-14; AZA was used at the dose of 75 mg/m2, day 1-7; HHT was given at a dose of 1mg/m2, day 1-7. The dose of VEN was reduced to 100mg/d if co-administered with posaconazole or voriconazole. |
| DRUG | VEN+HMA regimen | VEN was prescribed as 100mg day 1, 200mg day 2, 400mg day 3-28; AZA was used at the dose of 75 mg/m2, day 1-7 or DEC 20mg/m2 day 1-5. The dose of VEN was reduced to 100mg/d if co-administered with posaconazole or voriconazole. |
Timeline
- Start date
- 2018-12-03
- Primary completion
- 2022-05-31
- Completion
- 2022-05-31
- First posted
- 2022-07-13
- Last updated
- 2022-07-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05456048. Inclusion in this directory is not an endorsement.