Relapsed Acute Myeloid LeukemiaNCT05456048
Influence of Molecular Abnormalities on Response of VAH vs. VEN+HMA in RR-AML
An observational study of Relapsed Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the salvage therapy of RR-AML. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Gene Abnormality
- What is being tested?
- VAH regimen and VEN+HMA regimen
- How many people
- 231 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2018to 31 May 2022
- Phase
- Observational
- 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
Study population: Cases included in this study were from 3 previous studies of our study group, including 1 exploratory and 2 prospective studies.
Who may be able to join
- RR-AML
- Patients must have been treated for at least one cycle of VEN-based regimen and finished outcome assessment.
Who cannot join
- Acute promyelocytic leukemia (AML subtype M3)
- Previous exposure to the treatment of VEN-based regimen
- 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 (ALT) or aspartate aminotransferase (AST) ≥2 times the ULN)
- Renal dysfunction (creatinine ≥2 times the ULN or creatinine clearance rate < 30 mL/min)
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- ECOG performance status 3, 4 or 5
- Substantial history of neurological, psychiatric, endocrine, metabolic, immunological, or any other medical condition not suitable for the trial (investigators' decision)
- Active acute or chronic graft-versus-host disease (GVHD). Active acute GVHD or chronic GVHD is defined as GVHD requiring either at least 1 mg/kg per day of prednisone (or equivalent) or treatment beyond systemic corticosteroids.
- Patients with pregnancy
- Uncontrolled active infection
- Clinically significant coagulation abnormalities
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: Influence of Molecular Abnormalities on Treatment Response of the Regimen of Venetoclax Plus Azacytidine Combined With Homoharringtonine Versus Venetoclax Plus Hypomethylating Agents (HMA) in Relapsed/Refractory Acute Myeloid Leukemia
The aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the salvage therapy of RR-AML.
Read the detailed description
Venetoclax-based regimens have heen used in the salvage therapy of relapsed/resfractory (RR) acute myeloid leukemia (AML). More and more studies have shown that molecular abnormalities and venetoclax combined regimens significantly impact the response of venetoclax-based therapy. Our exploratory study revealed that venetoclax plus azacytidine combined with homoharringtonine (VAH) had remarkably higher response than venetoclax plus hypomethylating agents (HMA) in RR-AML. Yet the influence of molecular abnormalities on the response of VAH regimen remains unknown.
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Gene Abnormality, Cytogenetic Abnormality
- Being tested
- VAH regimen, VEN+HMA regimen
- Keywords
- Acute myeloid leukemia, Relapsed/refractory, Gene mutation, Venetoclax, Homoharringtonine
- Medical subject headings
- Leukemia, Myeloid, Acute, Chromosome Aberrations, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAH regimenDrug
VEN was prescribed as 100mg day 1, 200mg day 2, 400mg day 3-14; AZA was used at the dose of 75 mg/m2, day 1-7; HHT was given at a dose of 1mg/m2, day 1-7. The dose of VEN was reduced to 100mg/d if co-administered with posaconazole or voriconazole.
VEN+HMA regimenDrug
VEN was prescribed as 100mg day 1, 200mg day 2, 400mg day 3-28; AZA was used at the dose of 75 mg/m2, day 1-7 or DEC 20mg/m2 day 1-5. The dose of VEN was reduced to 100mg/d if co-administered with posaconazole or voriconazole.
| Study group | Role | What they receive |
|---|---|---|
| VAH group | Patients assigned to this group received one to two cycles of VAH regimen as salvage therapy of RR-AML. Receives: Drug: VAH regimen | |
| VEN+HMA group | Patients assigned to this group received one to two cycles of venetoclax plus HMA regimen as salvage therapy of RR-AML. Receives: Drug: VEN+HMA regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR/CRi
Complete remission and CR with incomplete count recovery
Measured: At the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes (4)
MRD negative
MRD was detected with FCM and defined negative as a ratio < 0.1%
Measured: At the end of Cycle 2 (each cycle is 28 days)
Overall response
Overall response included CR/CRi, MLFS and PR.
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: 2 years
Event-free survival
The time from enrolling to no response, relapse, death or the last follow up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start3 Dec 2018
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 231 participants (actual)
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, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Qifa Liu, Nanfang Hospital, Southern Medical University
- Investigators
- Liu Qifa, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456048
- Sponsor's protocol ID
- VAH-AML-2022
- Status last verified
- Jul 2022
- First submitted
- 3 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Molecular Abnormalities on Treatment Response of the Regimen of Venetoclax Plus Azacytidine Combined With Homoharringtonine Versus Venetoclax Plus Hypomethylating Agents (HMA) in Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05456048
- Acronym / sponsor ID
- VAH-AML-2022
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Gene Abnormality, Cytogenetic Abnormality
- Keywords
- Acute myeloid leukemia, Relapsed/refractory, Gene mutation, Venetoclax, Homoharringtonine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- 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, First Affiliated Hospital of Guangxi Medical University
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 13 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.
The aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the salvage therapy of RR-AML.
Detailed description
Venetoclax-based regimens have heen used in the salvage therapy of relapsed/resfractory (RR) acute myeloid leukemia (AML). More and more studies have shown that molecular abnormalities and venetoclax combined regimens significantly impact the response of venetoclax-based therapy. Our exploratory study revealed that venetoclax plus azacytidine combined with homoharringtonine (VAH) had remarkably higher response than venetoclax plus hypomethylating agents (HMA) in RR-AML. Yet the influence of molecular abnormalities on the response of VAH regimen remains unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAH group | – | Drug: VAH regimenPatients assigned to this group received one to two cycles of VAH regimen as salvage therapy of RR-AML. |
| VEN+HMA group | – | Drug: VEN+HMA regimenPatients assigned to this group received one to two cycles of venetoclax plus HMA regimen as salvage therapy of RR-AML. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases included in this study were from 3 previous studies of our study group, including 1 exploratory and 2 prospective studies.
Key inclusion criteria (2 listed)
- RR-AML
- Patients must have been treated for at least one cycle of VEN-based regimen and finished outcome assessment.
Key exclusion criteria (12 listed)
- Acute promyelocytic leukemia (AML subtype M3)
- Previous exposure to the treatment of VEN-based regimen
- 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 (ALT) or aspartate aminotransferase (AST) ≥2 times the ULN)
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 |
|---|---|---|
| VAH regimenVEN was prescribed as 100mg day 1, 200mg day 2, 400mg day 3-14; AZA was used at the dose of 75 mg/m2, day 1-7; HHT was given at a dose of 1mg/m2, day 1-7. The dose of VEN was reduced to 100mg/d if co-administered with posaconazole or voriconazole. | Drug | VAH group |
| VEN+HMA regimenVEN was prescribed as 100mg day 1, 200mg day 2, 400mg day 3-28; AZA was used at the dose of 75 mg/m2, day 1-7 or DEC 20mg/m2 day 1-5. The dose of VEN was reduced to 100mg/d if co-administered with posaconazole or voriconazole. | Drug | VEN+HMA group |
Primary outcome
CR/CRi
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Complete remission and CR with incomplete count recovery
4 secondary outcomes
MRD negative
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Overall response
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Overall survival
Time frame: 2 years
Event-free survival
Time frame: 2 years
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 13 Jul 2022.
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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.
Liu Qifa, MD 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?
An observational study of Relapsed Acute Myeloid Leukemia and Refractory Acute Myeloid 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 2 inclusion and 12 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 13 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.
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?
CR/CRi (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 13 Jul 2022.