- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05356169
Intensive Therapy Combined With Venetoclax for Adult Acute Myeloid Leukemia
April 29, 2022 updated by: Institute of Hematology & Blood Diseases Hospital
A Phase 2/3 Prospective, Randomized, Controlled, Parallel Group Study of Intensive Therapy Combined With Venetoclax for Newly Diagnosed Adult Acute Myeloid Leukemia
300 patients will be randomly distributed into the control group (n=150) and the experimental group(n=150).
Patients will receive two cycles of induction chemotherapy.
The control group receives standard 3+7 induction regimen containing cytarabine (100mg/m2 d1-7) and daunorubicin (60mg/m2 d1-3).
The experimental group receives venetoclax combined with intensive chemotherapy (3+7 induction regimen same as the control group).
For each group, patients who fail to achieve CR/CRi after two courses of induction therapy may receive alternative therapy decided by their physicians.
After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks: subjects in favorable risk group should continue with chemotherapy; subjects in poor risk group should go through transplantation; for subjects in intermediate risk group, those with suitable donors can receive transplantation while others can continue with consolidation therapy.
Subjects receive 3 courses of intermediate-dose cytarabine (1.5g/m2 q12h d1, 3, 5) for age>55 years or high dose cytarabine (3g/m2 q12h d1, 3, 5) for age≤ 55 years as consolidation therapy with venetoclax in experimental group and without venetoclax in control group.
After consolidation, patients will be observed.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianxiang Wang, Dr
- Phone Number: 86-22-23909120
- Email: wangjx@medmail.com.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with newly diagnosed AML (except for APL subtype) according to 2016 World Health Organization (WHO) classification and have not received chemotherapy before.
- Age ≥18 years and ≤65 years.
- Patient considered eligible for intensive chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at randomization.
- Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance >40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR).
- Adequate hepatic function as evidenced by:(1) Serum total bilirubin ≤ 1.5 × ULN unless considered due to Gilbert's disease, or leukemic involvement following approval by the Coordinating Investigator or Trial Coordinator;(2) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN, unless considered due to leukemic involvement following approval by the Coordinating Investigator or Trial Coordinator;(3)Myocardial enzyme<2.0×upper limit normal;(4)Left ventricular ejection fraction are within the normal range by measure of echocardiogram (ECHO)
- No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell [WBC] counts > 25x109/L).
- Able to understand and willing to sign an informed consent form (ICF).
Exclusion Criteria:
- AML with BCR-ABL1; or myeloid blast crisis of CML.
- Subjects who have received a prior treatment for AML with chemotherapy , hypomethylating agents or venetoclax before.
- Subjects with acute panmyelosis with myelofibrosis or myeloid sarcoma defined by WHO 2016.
- Subjects with a prior history of MDS, MPN or MDS/MPN.
- Subjects with other concurrent malignant tumors on treatment with the exception of basal or squamous cell carcinoma of the skin,carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic finding of prostate cancerand need treatment.
- Pregnant or lactating women.
- Active heart disease, defined as anyone of the followings:(1) Uncontrolled or symptomatic angina pectoris;(2) A myocardial infarction 6 months before enrolled; (3)Arrhythmia needed medication or with severe clinical symptoms;(4)Uncontrolled or symptomatic congestive heart failure (NYHA> grade 2);(5)Left ventricular ejection fraction below the lower limit of the normal range.
- Subjects with an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- Subjects with an active viral infection caused by HIV, hepatitis B or hepatitis C virus that cannot be controlled by treatment.
- Subjects with evidence of central nervous system leukemia before treatment.
- Subjects with epilepsy which needs drug treatment, dementia, or other abnormal mental state that can't understand or follow the protocol.
- Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Venetoclax combined with intensive chemotherapy
The experimental group receives two cycles of inducation chemotherapy consisting of venetoclax combined with standard DA 3+7 regimen.
After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks.
The consolidation chemotherapy regimen consists of three cycles of intermediate (for age>55 years)or high(for age≤ 55 years) dose cytarabine combined with venetoclax.
|
Bcl-2 inhibitor
|
ACTIVE_COMPARATOR: Intensive chemotherapy only
The control group receives two cycles of inducation chemotherapy consisting of standard DA 3+7 regimen without venetoclax.
After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks.
The consolidation chemotherapy regimen consists of three cycles of intermediate (for age>55 years)or high(for age≤ 55 years) dose cytarabine without venetoclax.
|
Bcl-2 inhibitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free survival
Time Frame: up to 12 months
|
The time from randomization to treatment failure, death from any cause or relapse after achieving CR or CRi, whichever occurs first.
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival Overall survival
Time Frame: up to 36 months
|
The time from randomization to death resulting from any cause
|
up to 36 months
|
CR rate
Time Frame: up to 2 months
|
The proportion of patients achieving CR after two cycles of induction chemotherapy.
|
up to 2 months
|
Rates of remission (CR/CRi) without measurable residual disease (CRMRD-)
Time Frame: up to 2 months
|
The proportion of AML patients achieving CR/CRi with negativity for a genetic marker by real-time quantitative polymerase chain reaction and/or with negativity by multi-color flow cytometry.
|
up to 2 months
|
Relapse free survival
Time Frame: up to 36 months
|
From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day.
|
up to 36 months
|
Cumulative incidence of relapse
Time Frame: up to 36 months
|
Calculated from tdate of first CR to the date of relapse, considering nonrelapse mortality (NRM) as a competing event
|
up to 36 months
|
Frequency and severity of AEs
Time Frame: up to 8 months
|
Adverse clinical events in the course of drug treatment according to CTCAE v5.0.
|
up to 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2022
Primary Completion (ANTICIPATED)
June 1, 2024
Study Completion (ANTICIPATED)
June 1, 2027
Study Registration Dates
First Submitted
April 19, 2022
First Submitted That Met QC Criteria
April 29, 2022
First Posted (ACTUAL)
May 2, 2022
Study Record Updates
Last Update Posted (ACTUAL)
May 2, 2022
Last Update Submitted That Met QC Criteria
April 29, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2021055-EC-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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