- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05659992
Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
December 13, 2022 updated by: Daihong Liu, Chinese PLA General Hospital
Single Arm,Open Label,Phase I Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML.
In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
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: Liping Dou
- Phone Number: +8613681207138
- Email: lipingruirui@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
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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
12 years to 73 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
- 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 active infection
- 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment group
Experimental: Venetoclax combined CACAG regimen for newly diagnosed AML.
All recipients in this arm received azacytidine, cytarabine.aclamycin,
chidamide,venetoclax and granulocyte colony-stimulating factor.Azacytidine was uesd as 75 mg/m2/day from day-1 to day-7.Cytarabine was uesd as 75 mg/m2 bid from day-1 to day-5.
Aclamycin was uesd as 10 mg/m2/day on day1,3,5).
Chidamide was uesd as 30 mg/day on days 0,3.
Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-14.Granulocyte colony-stimulating factor was uesd as 5ug/kg/day from day 0 until agranulocytosis recovery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: 2 months after 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).
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2 months after study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Remission (CR) Rate
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.
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2 months after study treatment
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CR with Incomplete Blood Count Recovery Rate
Time Frame: 2 months after study treatment
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All CR criteria except for residual neutropenia (<1.0 x 109/L (1000/µL)) or thrombocytopenia (<100 x 109/L (100,000/µL)
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2 months after study treatment
|
Partial Remission (PR) Rate:
Time Frame: 2 months after study treatment
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All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pre-treatment bone marrow blast percentage by at least 50 percent.
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2 months after study treatment
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Rate of Minimal Residual Disease (MRD)-Negative Response:
Time Frame: after two courses of chemotherapy (each course is 28 days)
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Percentage of participants who achieved MRD-negative response, defined as < 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry or < 0.01% as assessed by PCR of a bone marrow aspirate.
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after two courses of chemotherapy (each course is 28 days)
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Progression Free Survival (PFS)
Time Frame: 180 days after study treatment
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PFS was defined as time from the date joining the clinical study to the date of disease progression (PD) or date of death due to any cause, whichever occurred first.
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180 days after study treatment
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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.
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180 days after study treatment
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Rate of Participants With Adverse Events
Time Frame: Through 28 days post last study medication administration
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Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post last study medication administration.
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Through 28 days post last study medication administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Daihong Liu 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)
January 10, 2022
Primary Completion (Anticipated)
January 10, 2024
Study Completion (Anticipated)
January 10, 2024
Study Registration Dates
First Submitted
December 5, 2022
First Submitted That Met QC Criteria
December 13, 2022
First Posted (Actual)
December 21, 2022
Study Record Updates
Last Update Posted (Actual)
December 21, 2022
Last Update Submitted That Met QC Criteria
December 13, 2022
Last Verified
November 1, 2022
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
- Venetoclax
- Azacitidine
- Cytarabine
Other Study ID Numbers
- S2022-240
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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