- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06068621
Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
September 29, 2023 updated by: Daihong Liu, Chinese PLA General Hospital
Multicenter,Open Label,Phase 2 Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction.
In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML.
In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Phase 2
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: Daihong Liu, doctor
- Phone Number: +8613681171597
- Email: daihongrm@163.com
Study Contact Backup
- Name: Liping Dou, Doctor
- Phone Number: +8613681207138
- Email: lipingruirui@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
Contact:
- Daihong Liu, Doctor
- Phone Number: 86-13681171597
- Email: daihongrm@163.com
-
Contact:
- Liping Dou, Doctor
- Phone Number: 86-13681207138
- Email: lipingruirui@163.com
-
Principal Investigator:
- Daihong Liu, Doctor
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Patients who are able to understand and willing to sign the informed consent form (ICF).
- All patients should aged 14 to75 years,no gender limitation.
- Patients who are newly diagnosed with AML(no M3).
- Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
- Renal function: creatinine ≤the upper limit of normal;
- Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
- The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.
- Patients without severe allergic constitution.
Exclusion Criteria:
- Patients with allergy or contraindication to the study drug;
- Female patients who are pregnant or breast-feeding.
- Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
- Patients with mental illness or other states unable to comply with the protocol;
- Less than 6 weeks after surgical operation of important organs.
- Liver function: ALT and AST>2.5 times the upper limit of normal ,bilirubin> 2 times the upper limit of normal;Renal function: creatinine >the upper limit of normal;
- The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Venetoclax Combined With CACAG Regimen
Venetoclax combined with CACAG regimen for newly diagnosed AML.
Recipients were randomized and those entering the experimental group received azacytidine, cytarabine,aclacinomycin,chidamide,venetoclax and granulocyte colony-stimulating factor.
Azacytidine was used as 75 mg/m2/day from day 1 to day 7. Cytarabine was used as 75-100 mg/m2 bid from day 1 to day 5. Aclacinomycin was used as 20 mg/day on days 1,3,5.
Chidamide was used as 30 mg/day on days 1,4,8,11.
Venetoclax was used as 400 mg/day from day 1 to day 14;Combined with posaconazole, reduced to 100 mg/day;Combined with voriconazole, reduced to 200 mg/day.Granulocyte colony-stimulating factor was used as 300 μg/day from day 0 until agranulocytosi recovery .
|
Other Names:
|
Active Comparator: "3+7" Regimen
Idarubicin+cytarabine(IA) regimen or daunorubicin+cytarabine(DA) regimen for newly diagnosed AML.Recipients were randomized and those entering this group received IA or DA induction chemotherapy.
With the IA regimen,recipients received idarubicin(8-10 mg/m2) for three days and cytarabine(75-100 mg/m2, every 12 hrs) for seven days.
With the DA regimen,recipients received daunorubicin(60 mg/m2)for three days and cytarabine(75-100 mg/m2,every 12 hrs)for seven days.
|
IA regimen:
DA regimen:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR) after 1 course of treatment
Time Frame: 1 months after the start of study treatment
|
Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq.
Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.
|
1 months after the start of study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: 180 days after study treatment
|
Defined as the time from joining the clinical study to death due to any cause.
|
180 days after study treatment
|
Complete Remission (CR) Rate after 1 course of treatment
Time Frame: 2 months after study treatment
|
Defined in accordance with the IWG Response Criteria in AML.
Bone marrow blasts<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.
|
2 months after study treatment
|
Complete Remission (CR) Rate after 2 courses of treatment
Time Frame: after two courses of chemotherapy (each course is 28 days)
|
Defined in accordance with the IWG Response Criteria in AML.
Bone marrow blasts<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.
|
after two courses of chemotherapy (each course is 28 days)
|
Overall Response Rate (ORR) after 2 course of treatment
Time Frame: after two courses of chemotherapy (each course is 28 days)
|
Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq.
Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.
|
after two courses of chemotherapy (each course is 28 days)
|
Rate of Minimal Residual Disease (MRD)-Negative Response
Time Frame: after two courses of chemotherapy (each course is 28 days)
|
Percentage of participants who achieved MRD-negative response, defined as < 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry.
|
after two courses of chemotherapy (each course is 28 days)
|
Event-free survival
Time Frame: 180 days after study treatment
|
Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first.
|
180 days after study treatment
|
Treatment-related adverse events
Time Frame: From the first dose of study treatment to 30 days after the discontinuation of treatment
|
Defined as adverse events that occurred from the first dose of study treatment to 30 days after the discontinuation of treatment.
|
From the first dose of study treatment to 30 days after the discontinuation of treatment
|
Early death
Time Frame: Within 30 days of the start of the first course of treatment
|
Defined as death within 30 days of chemotherapy.
|
Within 30 days of the start of the first course of treatment
|
Disease-free survival
Time Frame: 180 days after study treatment
|
Defined as the time interval from disease remission to the occurrence of relapse or death,whichever came first.
|
180 days after study treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Daihong Liu, doctor, Chinese PLA General Hospital
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 (Actual)
August 1, 2023
Primary Completion (Estimated)
January 31, 2026
Study Completion (Estimated)
January 31, 2026
Study Registration Dates
First Submitted
September 29, 2023
First Submitted That Met QC Criteria
September 29, 2023
First Posted (Actual)
October 5, 2023
Study Record Updates
Last Update Posted (Actual)
October 5, 2023
Last Update Submitted That Met QC Criteria
September 29, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Antibiotics, Antineoplastic
- Venetoclax
- Lenograstim
- Azacitidine
- Cytarabine
- Aclacinomycins
Other Study ID Numbers
- S2023-056-01
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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