Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML
Primary Purpose
Refractory Acute Myeloid Leukemia, Relapsed Acute Erythroid Leukemia, Salvage Treatment
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HVA Regimens as Salvage Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Acute Myeloid Leukemia
Eligibility Criteria
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)
Sites / Locations
- Department of Hematology,Nanfang Hospital, Southern Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HVA treatment
Arm Description
All patients with rrAML are treated with HVA regimen
Outcomes
Primary Outcome Measures
Complete response
Blast rate lower than 5% with or without peripheral blood cell recover
Secondary Outcome Measures
Safety and Tolerability of HVA treatment
The number of participants experiencing 3/4 degree bone marrow suppession and infection.
Disease-free survival
Overall survival
Full Information
NCT ID
NCT04424147
First Posted
June 4, 2020
Last Updated
October 24, 2022
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Shenzhen Second People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Maoming People's Hospital, Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Shenzhen Hospital, Southern Medical University, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, The First People's Hospital of Chenzhou, Peking University Shenzhen Hospital, Zhongshan People's Hospital, Guangdong, China
1. Study Identification
Unique Protocol Identification Number
NCT04424147
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
June 16, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Shenzhen Second People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Maoming People's Hospital, Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Shenzhen Hospital, Southern Medical University, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, The First People's Hospital of Chenzhou, Peking University Shenzhen Hospital, Zhongshan People's Hospital, Guangdong, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Acute Myeloid Leukemia, Relapsed Acute Erythroid Leukemia, Salvage Treatment, HVA Regimen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients with rrAML are treated with HVA regimen
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HVA treatment
Arm Type
Experimental
Arm Description
All patients with rrAML are treated with HVA regimen
Intervention Type
Combination Product
Intervention Name(s)
HVA Regimens as Salvage Treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete response
Description
Blast rate lower than 5% with or without peripheral blood cell recover
Time Frame
At the end of Cycle 2 (each cycle is 28 days)
Secondary Outcome Measure Information:
Title
Safety and Tolerability of HVA treatment
Description
The number of participants experiencing 3/4 degree bone marrow suppession and infection.
Time Frame
At the end of Cycle 2 (each cycle is 28 days)
Title
Disease-free survival
Time Frame
one year
Title
Overall survival
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qifa Liu
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology,Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML
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