Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04424147

Collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other), Guangzhou First People's Hospital (Other), Peking University People's Hospital (Other), Southern Medical University, China (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other)

Enrollment

Location

Arm

36.1

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractory Acute Myeloid Leukemia Relapsed Acute Erythroid Leukemia Salvage Treatment HVA Regimen	Combination Product: HVA Regimens as Salvage Treatment	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients with rrAML are treated with HVA regimenPatients with rrAML are treated with HVA regimen

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 27, 2020

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HVA treatment All patients with rrAML are treated with HVA regimen	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

Arm

Intervention/Treatment

Experimental: HVA treatment

All patients with rrAML are treated with HVA regimen

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

Outcome Measures

Primary Outcome Measures

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

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.
Disease-free survival [one year]
Overall survival [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou First People's Hospital
Peking University People's Hospital
Southern Medical University, China
Third Affiliated Hospital, Sun Yat-Sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qifa Liu, Professor, Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT04424147

Other Study ID Numbers:

HVA in rrAML

First Posted:

Jun 9, 2020

Last Update Posted:

Jun 9, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Erythroblastic, Acute

Study Results

No Results Posted as of Jun 9, 2020