Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML

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.

Conditions

• Refractory Acute Myeloid Leukemia
• Relapsed Acute Erythroid Leukemia
• Salvage Treatment
• HVA Regimen

Interventions

COMBINATION_PRODUCT

HVA Regimens as Salvage Treatment

venetoclax with a dose of 400mg per day for 14 days, combined with azacitidine (AZA) with a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days

Sponsors & Collaborators

• Shenzhen Second People's Hospital

  collaborator OTHER

• The Seventh Affiliated Hospital of Sun Yat-sen University

  collaborator OTHER

• Maoming People's Hospital

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Shenzhen Hospital, Southern Medical University

  collaborator UNKNOWN

• Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator UNKNOWN

• The First People's Hospital of Chenzhou

  collaborator UNKNOWN

• Peking University Shenzhen Hospital

  collaborator OTHER

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Qifa Liu · Nanfang Hospital, Southern Medical University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-27

Primary Completion

2021-06-16

Completion

2022-06-30

Countries

• China

Study Locations