Acute Myeloid Leukemia, AdultPhase 2NCT04752527
Individualized Induction Therapy for Non-elderly Acute Myeloid Leukemia Patients With Adverse Risk Features
A Phase 2 study testing venetoclax combined with decitabine in people with Acute Myeloid Leukemia, Adult, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Individualized induction therapy will be applied to the non-elderly acute myeloid leukemia (AML) patients with adverse genetic risk features guided by rapid screening with fluorescence in situ hybridization (FISH) and next-generation sequencing (NGS), such as the combination of Venetoclax plus decitabine, and… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Acute Myeloid Leukemia, Adult
- What is being tested?
- venetoclax combined with decitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2021to Dec 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, 59 > =Age (years) >= 18;
- Newly diagnosed as AML patients according to World Health Organization (WHO) classification;
- AML patients meet the adverse risk group according to 2017 European Leukemia Net risk stratification;
- Patients have not received prior therapy for AML (except HU);
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
- Liver function: Total bilirubin ≦3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN(except extramedullary infiltration of leukemia)
- Renal function：Ccr ≧30 ml/min;
- Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
Who cannot join
- Acute promyeloid leukemia；
- AML with central nervous system (CNS) infiltration；
- Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
- HIV infection;
- Patients with severe heart failure (grade 3-4) ;
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Uncontrolled and/or active systemic infection (viral, bacterial or fungal); b) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. c)An active second cancer that requires treatment within 6 months of study entry
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- Patients deemed unsuitable for enrolment by the investigator;
- Patients willing to receive intensive induction chemotherapy
- Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen；
- Patients reject to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, 215000
Suning Chen, 13814881746, chensuning@sina.com
About this study
Official title: The Clinical Study of Individualized Induction Therapy for Non-elderly Patients With Acute Myeloid Leukemia and Adverse Risk Features Guided by Rapid Screening With FISH and NGS
Individualized induction therapy will be applied to the non-elderly acute myeloid leukemia (AML) patients with adverse genetic risk features guided by rapid screening with fluorescence in situ hybridization (FISH) and next-generation sequencing (NGS), such as the combination of Venetoclax plus decitabine, and Sorafenib for patients with high (FMS)-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) allelic ratio. This study aims to improve induction therapy for non-elderly AML patients with adverse genetic risk features, reduce treatment-related complications, and improve overall survival.
Read the detailed description
The non-elderly AML patients who meet the adverse risk group defined as 2017 European LeukemiaNet (ELN) risk stratification, are more likely to be refractory to intensive induction and have low rates of long-term survival. Venetoclax (drug name) plus decitabine or azacitidine showed tolerable safety and favorable overall response rate (ORR )(complete remission (CR)+CR with incomplete hematologic recovery (CRi) rate: 67%) in elderly AML patients. In addition, combination therapy with sorafenib, cytarabine and idarubicin was able to induce a high CR rate in non-elderly AML patients with FLT3 mutations and a 1-year probability of survival of 74%. The fast next-generation sequencing together with FISH can identify the adverse genetic risk features in AML patients within 72 hours. Individualized induction therapy will be applied to the non-elderly AML patients with adverse genetic risk features guided by rapid screening with FISH and NGS, such as the combination of venetoclax plus decitabine, and Sorafenib for patients with high FLT3-ITD allelic ratio. This study aims to improve induction therapy for non-elderly AML patients with adverse genetic risk features, reduce treatment-related complications, and improve overall survival.
- Conditions
- Acute Myeloid Leukemia, Adult
- Being tested
- venetoclax combined with decitabine
- 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.
venetoclax combined with decitabineDrug
Also called combination of venetoclax plus decitabine with or without sorafenib
combination of venetoclax plus decitabine, and sorafenib for patients with high FLT3-ITD allelic ratio. (On day 1 of cycle 1, decitabine 20 mg/m2 will be given intravenously, and will continue for 5 days. Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 28 day cycle is finished. For patients with high FLT3-ITD allelic ratio, sorafenib was administered at a dose of 400mg orally twice daily, on days 3 through 28.
| Study group | Role | What they receive |
|---|---|---|
| Treatment regime | Experimental | combination of venetoclax plus azacitidine, and Sorafenib for patients with high FLT3-ITD allelic ratio Receives: Drug: venetoclax combined with decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR/CRi/morphologic leukemia free state (MLFS)
Complete remission/complete remission with incomplete count recovery/Morphologic Leukemia Free State（after one cycle or two cycles of induction therapy）
Measured: Study start date to study end date, or death, whichever comes first, up to 4 years
Secondary outcomes (3)
Event Free Survival(EFS)
Event Free Survival
Measured: Study start date to study end date, or death, whichever comes first, up to 4 years
Overall Survival(OS)
Overall Survival
Measured: Study start date to study end date, or death, whichever comes first, up to 4 years
Incidence of Adverse Events
infection, blood transfusion, and other toxicity
Measured: Study start date to study end date, or death, whichever comes first, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start20 Feb 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, AdultStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752527
- Sponsor's protocol ID
- SZ-AML01
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Individualized Induction Therapy for Non-elderly Patients With Acute Myeloid Leukemia and Adverse Risk Features Guided by Rapid Screening With FISH and NGS
- ClinicalTrials.gov ID
- NCT04752527
- Acronym / sponsor ID
- SZ-AML01
- Conditions
- Acute Myeloid Leukemia, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Feb 2021 (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.
Individualized induction therapy will be applied to the non-elderly acute myeloid leukemia (AML) patients with adverse genetic risk features guided by rapid screening with fluorescence in situ hybridization (FISH) and next-generation sequencing (NGS), such as the combination of Venetoclax plus decitabine, and Sorafenib for patients with high (FMS)-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) allelic ratio. This study aims to improve induction therapy for non-elderly AML patients with adverse genetic risk features, reduce treatment-related complications, and improve overall survival.
Detailed description
The non-elderly AML patients who meet the adverse risk group defined as 2017 European LeukemiaNet (ELN) risk stratification, are more likely to be refractory to intensive induction and have low rates of long-term survival. Venetoclax (drug name) plus decitabine or azacitidine showed tolerable safety and favorable overall response rate (ORR )(complete remission (CR)+CR with incomplete hematologic recovery (CRi) rate: 67%) in elderly AML patients. In addition, combination therapy with sorafenib, cytarabine and idarubicin was able to induce a high CR rate in non-elderly AML patients with FLT3 mutations and a 1-year probability of survival of 74%. The fast next-generation sequencing together with FISH can identify the adverse genetic risk features in AML patients within 72 hours. Individualized induction therapy will be applied to the non-elderly AML patients with adverse genetic risk features guided by rapid screening with FISH and NGS, such as the combination of venetoclax plus decitabine, and Sorafenib for patients with high FLT3-ITD allelic ratio. This study aims to improve induction therapy for non-elderly AML patients with adverse genetic risk features, reduce treatment-related complications, and improve overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment regime | Experimental | Drug: venetoclax combined with decitabinecombination of venetoclax plus azacitidine, and Sorafenib for patients with high FLT3-ITD allelic ratio |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female, 59 > =Age (years) >= 18;
- Newly diagnosed as AML patients according to World Health Organization (WHO) classification;
- AML patients meet the adverse risk group according to 2017 European Leukemia Net risk stratification;
- Patients have not received prior therapy for AML (except HU);
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
Key exclusion criteria (10 listed)
- Acute promyeloid leukemia；
- AML with central nervous system (CNS) infiltration；
- Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
- HIV infection;
- Patients with severe heart failure (grade 3-4) ;
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 |
|---|---|---|
| venetoclax combined with decitabineAlso: combination of venetoclax plus decitabine with or without sorafenibcombination of venetoclax plus decitabine, and sorafenib for patients with high FLT3-ITD allelic ratio. (On day 1 of cycle 1, decitabine 20 mg/m2 will be given intravenously, and will continue for 5 days. Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 28 day cycle is finished. For patients with high FLT3-ITD allelic ratio, sorafenib was administered at a dose of 400mg orally twice daily, on days 3 through 28. | Drug | Treatment regime |
Primary outcome
CR/CRi/morphologic leukemia free state (MLFS)
Time frame: Study start date to study end date, or death, whichever comes first, up to 4 years
Complete remission/complete remission with incomplete count recovery/Morphologic Leukemia Free State（after one cycle or two cycles of induction therapy）
3 secondary outcomes
Event Free Survival(EFS)
Time frame: Study start date to study end date, or death, whichever comes first, up to 4 years
Overall Survival(OS)
Time frame: Study start date to study end date, or death, whichever comes first, up to 4 years
Incidence of Adverse Events
Time frame: Study start date to study end date, or death, whichever comes first, up to 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
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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.
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 venetoclax combined with decitabine in people with Acute Myeloid Leukemia, Adult, run by The First Affiliated Hospital of Soochow 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 8 inclusion and 10 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 15 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact suning chen, professor (8613814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR/CRi/morphologic leukemia free state (MLFS) (time frame: Study start date to study end date, or death, whichever comes first, up to 4 years). 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 15 Nov 2021.