Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML

Phase 2

Completed

• Conditions: Refractory Acute Myeloid Leukemia; Salvage Treatment; Relapsed Acute Erythroid Leukemia; HVA Regimen
• Interventions: Combination Product: HVA Regimens as Salvage Treatment

• Registration Number: NCT04424147
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Up Until now, there is not well acepted treatment for relapsed/refractory (rr) acute myeloid luekemia (AML), which has low complete response and poor survival. According to different guildlines, clinical trial is the first choice for the treatment of rrAML. High expression of BCL-2 and hypermethylation are very important factors for drug resistance in AML. Lots of studies have reported combination of BCL-2 inhibitor with hypomethylating agents (HMA) showed a promising efficacy in elder or unfit patients with newly diagnosed AML, however, presented not that exciting curing effect in rrAML. It is known that overexpression of MCL-1 and BCL-XL is the main reason for leukemia cells being resistant to BCL2 inhibitors. Since Homoharringtonine (HHT) could downregulate MCL-1 and BCL-XL in leukemia cells, there might be a synergic effect for combination of BCL-2 inhibitors with HHT, which has been proven in the treatment of lymphoma. Yet, there is not a report for the use of this combination in AML. In this single arm multi-centers prospective study, adult patients with rrAML are included and treated with BCL-2 inhibitor venetoclax at a dose of 400mg per day for 14 days, combined with azacitidine (AZA) at a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days, and then the eficacy and safety of HVA regimens as salvage treatment in rrAML are assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-27
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-07
• Study First Posted: 2020-06-09
• Primary Completion: 2021-06-16
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Patients with rrAML Patients with the age of 18-65 years old

Exclusion Criteria

• Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
• Patients with any conditions not suitable for the trial (investigators' decision)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HVA treatment	HVA Regimens as Salvage Treatment	All patients with rrAML are treated with HVA regimen

Primary Outcome Measures

Name	Time	Method
Complete response	At the end of Cycle 2 (each cycle is 28 days)	Blast rate lower than 5% with or without peripheral blood cell recover

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	one year
Overall survival	one year
Safety and Tolerability of HVA treatment	At the end of Cycle 2 (each cycle is 28 days)	The number of participants experiencing 3/4 degree bone marrow suppession and infection.

Trial Locations

Locations (1)

Department of Hematology,Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China