Venetoclax Combined With Azacitidine Plus HomoharringtoninePhase 3NCT05457361
VAH Versus VA for Salvage Therapy of R/R-AML
A Phase 3 study testing VEN combined with azacitidine plus homoharringtonine and VEN combined with azacitidine in people with Venetoclax Combined With Azacitidine Plus Homoharringtonine and Venetoclax Combined With Azacitidine, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This is a prospective, multi-center, phase 3 randomized controlled clinical study comparing VAH and VA regimens for the salvage treatment of the patients with relapsed/refractory AML. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Venetoclax Combined With Azacitidine Plus Homoharringtonine, Venetoclax Combined With Azacitidine
- What is being tested?
- VEN combined with azacitidine plus homoharringtonine and VEN combined with azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Dec 2023
- Phase
- Phase 3
- 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 relapsed/refractory AML The diagnosis of AML or relapsed AML was based on the criteria from NCCN, defined as recurrence of blasts in the peripheral blood (PB) or bone marrow (BM) blasts > 5% or development of extramedullary disease of patients after achieving a CR. Refractory AML was defined as no composite complete remission (CRc) and a reduction in bone marrow blasts of less than 50% after one cycle or no CRc after two cycles.
- Age 18 to 65 years old with Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Sign informed consent form, have the ability to comply with study and follow-up procedures
Who cannot join
- Acute promyelocytic leukemia (AML subtype M3)
- Previous exposure to the treatment of VEN-based regimen
- Life expectancy less than 30 days after salvage therapy
- Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- Respiratory failure ( PaO2 ≤60mmHg)
- Hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal [ULN], alanine aminotransferase or aspartate aminotransferase ≥2 times the ULN)
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- Renal dysfunction (creatinine ≥2 times the ULN or creatinine clearance rate < 30 mL/min)
- ECOG performance status 3, 4 or 5
- With any conditions not suitable for the trial (investigators' decision)
- Active acute or chronic graft-versus-host disease (GVHD). Active acute GVHD or chronic GVHD was defined as GVHD requiring either at least 1 mg/kg per day of prednisone (or equivalent) or treatment beyond systemic corticosteroids.
- Patients with pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Qifa Liu, 86-20-61641612, liuqifa628@163.com
About this study
Official title: Venetoclax Combined With Azacitidine Plus Homoharringtonine Versus Venetoclax Combined With Azacitidine for Relapsed/Refractory Acute Myeloid Leukemia：an Open-label, Multicentre, Randomised Phase 3 Trial
This is a prospective, multi-center, phase 3 randomized controlled clinical study comparing VAH and VA regimens for the salvage treatment of the patients with relapsed/refractory AML. Approximately 164 subjects will be randomized in a 1:1 ratio to receive VAH regimen (82 subjects) or VA regimen (82 subjects) for salvage therapy. Randomization is done with permuted blocks (block size four), and implemented through an interactive web-based response system.
VAH regimen: VEN begins at 100 mg on day 1 and increases stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, 400 mg); dosing is continued at 400 mg per day from day 4 through day 14; azacitidine (75 mg/m²) is administered subcutaneously on days 1-7, and HHT (1 mg/m²) on days 1-7.
Read more
VA regimen: The use of VEN is just the same as it dose in VAH regimen except lasting for 28 days. The use of azacitidine is exactly the same as VAH group does.
The primary endpoint was overall response rate (ORR) after 2 cycles of trial therapy.
The secondary endpoints were CRc after 2 cycles of trial therapy, overall survival (OS), event-free survival (EFS) and relapse at 2 year, and safety.
- Conditions
- Venetoclax Combined With Azacitidine Plus Homoharringtonine, Venetoclax Combined With Azacitidine
- Being tested
- VEN combined with azacitidine plus homoharringtonine, VEN combined with azacitidine
- Keywords
- Relapsed/refractory acute myeloid leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEN combined with azacitidine plus homoharringtonineDrug
VEN begins at 100 mg on day 1 and increases stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, 400 mg); dosing is continued at 400 mg per day from day 4 through day 14; azacitidine (75 mg/m²) is administered subcutaneously on days 1-7, and HHT (1 mg/m²) on days 1-7.
VEN combined with azacitidineDrug
The use of VEN is just the same as it dose in VAH regimen except lasting for 28 days. The use of azacitidine is exactly the same as VAH group does.
| Study group | Role | What they receive |
|---|---|---|
| VAH regimen | Experimental | VEN begins at 100 mg on day 1 and increases stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, 400 mg); dosing is continued at 400 mg per day from day 4 through day 14; azacitidine (75 mg/m²) is administered subcutaneously on days 1-7, and HHT (1 mg/m²) on days 1-7. Receives: Drug: VEN combined with azacitidine plus homoharringtonine |
| VA regimen | Active comparator | The use of VEN is just the same as it dose in VAH regimen except lasting for 28 days. The use of azacitidine is exactly the same as VAH group does. Receives: Drug: VEN combined with azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Overall response including CR/CRi and PR
Measured: At the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes (5)
Composite complete remission rate
Composite complete remission including CR/CRi
Measured: At the end of Cycle 2 (each cycle is 28 days)
Overall survival
The time from enrolling to death or the last follow up
Measured: From date of randomization until date of death from any cause, assessed up to 12 months.
Event-free survival
The time from enrolling to no response, relapse, death or the last follow up
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Relapse
The event of relapse
Measured: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Haematological toxicity and non-haematological toxicity
Measured: Baseline to 30 day post the salvage therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venetoclax Combined With Azacitidine Plus HomoharringtonineStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhongshan People's Hospital, Guangdong, China, Shenzhen Hospital of Southern Medical University, Peking University Shenzhen Hospital, Shenzhen Second People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Southern Medical University, China, First People's Hospital of Chenzhou, The Affiliated Hospital of Qingdao University, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Qifa Liu, Nanfang Hospital, Southern Medical University
- Investigators
- Qifa Liu, Principal investigator, Department of Hematology,Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457361
- Sponsor's protocol ID
- VAH vs VA-2022
- Status last verified
- Jul 2022
- First submitted
- 8 Mar 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax Combined With Azacitidine Plus Homoharringtonine Versus Venetoclax Combined With Azacitidine for Relapsed/Refractory Acute Myeloid Leukemia：an Open-label, Multicentre, Randomised Phase 3 Trial
- ClinicalTrials.gov ID
- NCT05457361
- Acronym / sponsor ID
- VAH vs VA-2022
- Conditions
- Venetoclax Combined With Azacitidine Plus Homoharringtonine, Venetoclax Combined With Azacitidine
- Keywords
- Relapsed/refractory acute myeloid leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhongshan People's Hospital, Guangdong, China, Shenzhen Hospital of Southern Medical University, Peking University Shenzhen Hospital, Shenzhen Second People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Southern Medical University, China, First People's Hospital of Chenzhou, The Affiliated Hospital of Qingdao University, First Affiliated Hospital of Guangxi Medical University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Jul 2022 (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.
This is a prospective, multi-center, phase 3 randomized controlled clinical study comparing VAH and VA regimens for the salvage treatment of the patients with relapsed/refractory AML. Approximately 164 subjects will be randomized in a 1:1 ratio to receive VAH regimen (82 subjects) or VA regimen (82 subjects) for salvage therapy. Randomization is done with permuted blocks (block size four), and implemented through an interactive web-based response system.
VAH regimen: VEN begins at 100 mg on day 1 and increases stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, 400 mg); dosing is continued at 400 mg per day from day 4 through day 14; azacitidine (75 mg/m²) is administered subcutaneously on days 1-7, and HHT (1 mg/m²) on days 1-7.
VA regimen: The use of VEN is just the same as it dose in VAH regimen except lasting for 28 days. The use of azacitidine is exactly the same as VAH group does.
The primary endpoint was overall response rate (ORR) after 2 cycles of trial therapy.
The secondary endpoints were CRc after 2 cycles of trial therapy, overall survival (OS), event-free survival (EFS) and relapse at 2 year, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAH regimen | Experimental | Drug: VEN combined with azacitidine plus homoharringtonineVEN begins at 100 mg on day 1 and increases stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, 400 mg); dosing is continued at 400 mg per day from day 4 through day 14; azacitidine (75 mg/m²) is administered subcutaneously on days 1-7, and HHT (1 mg/m²) on days 1-7. |
| VA regimen | Active comparator | Drug: VEN combined with azacitidineThe use of VEN is just the same as it dose in VAH regimen except lasting for 28 days. The use of azacitidine is exactly the same as VAH group does. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with relapsed/refractory AML The diagnosis of AML or relapsed AML was based on the criteria from NCCN, defined as recurrence of blasts in the peripheral blood (PB) or bone marrow (BM) blasts > 5% or development of extramedullary disease of patients after achieving a CR. Refractory AML was defined as no composite complete remission (CRc) and a reduction in bone marrow blasts of less than 50% after one cycle or no CRc after two cycles.
- Age 18 to 65 years old with Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Sign informed consent form, have the ability to comply with study and follow-up procedures
Key exclusion criteria (11 listed)
- Acute promyelocytic leukemia (AML subtype M3)
- Previous exposure to the treatment of VEN-based regimen
- Life expectancy less than 30 days after salvage therapy
- Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- Respiratory failure ( PaO2 ≤60mmHg)
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 |
|---|---|---|
| VEN combined with azacitidine plus homoharringtonineVEN begins at 100 mg on day 1 and increases stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, 400 mg); dosing is continued at 400 mg per day from day 4 through day 14; azacitidine (75 mg/m²) is administered subcutaneously on days 1-7, and HHT (1 mg/m²) on days 1-7. | Drug | VAH regimen |
| VEN combined with azacitidineThe use of VEN is just the same as it dose in VAH regimen except lasting for 28 days. The use of azacitidine is exactly the same as VAH group does. | Drug | VA regimen |
Primary outcome
Overall response rate
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Overall response including CR/CRi and PR
5 secondary outcomes
Composite complete remission rate
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Overall survival
Time frame: From date of randomization until date of death from any cause, assessed up to 12 months.
Event-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Relapse
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Baseline to 30 day post the salvage therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: Yes
Related trials for Venetoclax Combined With Azacitidine Plus Homoharringtonine
Enrolling by invitationPhase 2
Homoharringtonine, Lisaftoclax, and Azacitidine for AML After Venetoclax-Based Therapy Failure
Acute Myeloid Leukemia (AML)
Not yet recruitingPhase 3
VAH vs VA in Newly Diagnosed Elderly AML
Acute Myeloid Leukemia (AML), Elderly Patients (60-75 Years)
Enrolling by invitationPhase 2
HVA in the Treatment of Mixed-Phenotype Acute Leukemia(MPAL).
Newly Diagnosed Mixed Phenotype Acute Leukemia (MPAL)
Not yet recruitingPhase 2
Exploratory Study of Venetoclax, Homoharringtonine, Azacitidine Plus G-CSF for Newly Diagnosed AML (VHAG)
Acute Myeloid Leukemia (AML)
Not yet recruitingPhase 2
Efficacy and Safety of Lisafotoclax Plus Decitabine and Homoharringtonine in Venetoclax/Azacitidine Pretreated AML Patients
Acute Myeloid Leukemia (AML)
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
Department of Hematology,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 3 study testing VEN combined with azacitidine plus homoharringtonine and VEN combined with azacitidine in people with Venetoclax Combined With Azacitidine Plus Homoharringtonine and Venetoclax Combined With Azacitidine, 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qifa Liu (86-20-61641612, liuqifa628@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (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?
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 14 Jul 2022.