Refractory Acute Myeloid LeukemiaPhase 2NCT04424147
Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML
A Phase 2 study testing HVA Regimens as Salvage Treatment in people with Refractory Acute Myeloid Leukemia and Relapsed Acute Erythroid Leukemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Refractory Acute Myeloid Leukemia, Relapsed Acute Erythroid Leukemia, Salvage Treatment
- What is being tested?
- HVA Regimens as Salvage Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2020to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rrAML Patients with the age of 18-65 years old
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: Efficacy and Safety of HVA Regimens as Salvage Treatment in Relapsed/Refractory (rr) Acute Myeloid Leukemia (AML)
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
- Being tested
- HVA Regimens as Salvage Treatment
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Erythroblastic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVA Regimens as Salvage TreatmentCombination product
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
| Study group | Role | What they receive |
|---|---|---|
| HVA treatment | Experimental | All patients with rrAML are treated with HVA regimen Receives: Combination Product: HVA Regimens as Salvage Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response
Blast rate lower than 5% with or without peripheral blood cell recover
Measured: At the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes (3)
Safety and Tolerability of HVA treatment
The number of participants experiencing 3/4 degree bone marrow suppession and infection.
Measured: At the end of Cycle 2 (each cycle is 28 days)
Disease-free survival
Measured: one year
Overall survival
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start27 May 2020
- Primary completion16 Jun 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refractory Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with rrAML are treated with HVA regimen
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Maoming People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Shenzhen Hospital of 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
- Responsible party
- Principal investigator, Qifa Liu, Nanfang Hospital, Southern Medical University
- Investigators
- Qifa Liu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424147
- Sponsor's protocol ID
- HVA in rrAML
- Status last verified
- Oct 2022
- First submitted
- 4 Jun 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu S, Zhang Y, Yu G, Wang Y, Shao R, Du X, Xu N, Lin D, Zhao W, Zhang X, Xiao J, Sun Z, Deng L, Liang X, Zhang H, Guo Z, Dai M, Shi P, Huang F, Fan Z, Liu Q, Lin R, Jiang X, Xuan L, Liu Q, Jin H. Sorafenib plus triplet therapy with venetoclax, azacitidine and homoharringtonine for refractory/relapsed acute myeloid leukemia with FLT3-ITD: A multicenter phase 2 study. J Intern Med. 2024 Feb;295(2):216-228. doi: 10.1111/joim.13738. Epub 2023 Oct 29.
PubMed 37899297Jin H, Zhang Y, Yu S, Du X, Xu N, Shao R, Lin D, Chen Y, Xiao J, Sun Z, Deng L, Liang X, Zhang H, Guo Z, Dai M, Shi P, Huang F, Fan Z, Yin Z, Xuan L, Lin R, Jiang X, Yu G, Liu Q. Venetoclax Combined with Azacitidine and Homoharringtonine in Relapsed/Refractory AML: A Multicenter, Phase 2 Trial. J Hematol Oncol. 2023 Apr 29;16(1):42. doi: 10.1186/s13045-023-01437-1.
PubMed 37120593
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HVA Regimens as Salvage Treatment in Relapsed/Refractory (rr) Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT04424147
- Acronym / sponsor ID
- HVA in rrAML
- Conditions
- Refractory Acute Myeloid Leukemia, Relapsed Acute Erythroid Leukemia, Salvage Treatment, HVA Regimen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Maoming People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Shenzhen Hospital of 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
- Study start
- 27 May 2020 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with rrAML are treated with HVA regimen
| Arm | Type | Receives |
|---|---|---|
| HVA treatment | Experimental | Combination Product: HVA Regimens as Salvage TreatmentAll patients with rrAML are treated with HVA regimen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with rrAML Patients with the age of 18-65 years old
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HVA Regimens as Salvage Treatmentvenetoclax 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 | Combination product | HVA treatment |
Primary outcome
Complete response
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Blast rate lower than 5% with or without peripheral blood cell recover
3 secondary outcomes
Safety and Tolerability of HVA treatment
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Disease-free survival
Time frame: one year
Overall survival
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 37899297Yu S, Zhang Y, Yu G, Wang Y, Shao R, Du X, Xu N, Lin D, Zhao W, Zhang X, Xiao J, Sun Z, Deng L, Liang X, Zhang H, Guo Z, Dai M, Shi P, Huang F, Fan Z, Liu Q, Lin R, Jiang X, Xuan L, Liu Q, Jin H. Sorafenib plus triplet therapy with venetoclax, azacitidine and homoharringtonine for refractory/relapsed acute myeloid leukemia with FLT3-ITD: A multicenter phase 2 study. J Intern Med. 2024 Feb;295(2):216-228. doi: 10.1111/joim.13738. Epub 2023 Oct 29.
- Derived from this study: PubMed 37120593Jin H, Zhang Y, Yu S, Du X, Xu N, Shao R, Lin D, Chen Y, Xiao J, Sun Z, Deng L, Liang X, Zhang H, Guo Z, Dai M, Shi P, Huang F, Fan Z, Yin Z, Xuan L, Lin R, Jiang X, Yu G, Liu Q. Venetoclax Combined with Azacitidine and Homoharringtonine in Relapsed/Refractory AML: A Multicenter, Phase 2 Trial. J Hematol Oncol. 2023 Apr 29;16(1):42. doi: 10.1186/s13045-023-01437-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qifa Liu principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HVA Regimens as Salvage Treatment in people with Refractory Acute Myeloid Leukemia and Relapsed Acute Erythroid Leukemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (time frame: At the end of Cycle 2 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04424147, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.