Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML

Brief Title

Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML

Official Title

Efficacy and Safety of HVA Regimens as Salvage Treatment in Relapsed/Refractory (rr) Acute Myeloid Leukemia (AML)

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Complete response

Secondary Outcome

 Safety and Tolerability of HVA treatment

Condition

Refractory Acute Myeloid Leukemia

Intervention

HVA Regimens as Salvage Treatment

Study Arms / Comparison Groups

 HVA treatment
Description:  All patients with rrAML are treated with HVA regimen

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Combination Product

Estimated Enrollment

40

Start Date

May 27, 2020

Completion Date

May 31, 2023

Primary Completion Date

May 31, 2022

Eligibility Criteria

        Inclusion Criteria:

        Patients with rrAML Patients with the age of 18-80 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)
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Qifa Liu, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04424147

Organization ID

HVA in rrAML


Responsible Party

Principal Investigator

Study Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

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

Study Sponsor

Qifa Liu, Principal Investigator, Nanfang Hospital of Southern Medical University


Verification Date

June 2020