Back to resultsClinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Venetoclax, CACAG, AML
Eligibility Criteria
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.)
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
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).
Secondary Outcome Measures
Complete Remission (CR) Rate
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.
CR with Incomplete Blood Count Recovery Rate
All CR criteria except for residual neutropenia (<1.0 x 109/L (1000/µL)) or thrombocytopenia (<100 x 109/L (100,000/µL)
Partial Remission (PR) Rate:
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.
Rate of Minimal Residual Disease (MRD)-Negative Response:
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.
Progression Free Survival (PFS)
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.
Overall Survival (OS)
Defined as the time from joining the clinical study to death due to any cause.
Rate of Participants With Adverse Events
Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post last study medication administration.
Full Information
NCT ID
NCT05659992
First Posted
December 5, 2022
Last Updated
December 13, 2022
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05659992
Brief Title
Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Official Title
Single Arm,Open Label,Phase I Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
January 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
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
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Venetoclax, CACAG, AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte
Intervention Description
azacytidine (75 mg/m2/day, days 1 to 7).
cytarabine (75 mg/m2 bid, days 1 to 5).
aclamycin (10 mg/m2/day, day1,3,5).
Chidamide (30 mg/day , days 0,3).
venetoclax (100 mg day 1, 200 mg day 2, 400mg days 3 to 14 ).
granulocyte colony-stimulating factor (5ug/kg/day, day 0 until agranulocytosis recovery)
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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).
Time Frame
2 months after study treatment
Secondary Outcome Measure Information:
Title
Complete Remission (CR) Rate
Description
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.
Time Frame
2 months after study treatment
Title
CR with Incomplete Blood Count Recovery Rate
Description
All CR criteria except for residual neutropenia (<1.0 x 109/L (1000/µL)) or thrombocytopenia (<100 x 109/L (100,000/µL)
Time Frame
2 months after study treatment
Title
Partial Remission (PR) Rate:
Description
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.
Time Frame
2 months after study treatment
Title
Rate of Minimal Residual Disease (MRD)-Negative Response:
Description
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.
Time Frame
after two courses of chemotherapy (each course is 28 days)
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
180 days after study treatment
Title
Overall Survival (OS)
Description
Defined as the time from joining the clinical study to death due to any cause.
Time Frame
180 days after study treatment
Title
Rate of Participants With Adverse Events
Description
Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post last study medication administration.
Time Frame
Through 28 days post last study medication administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daihong Liu, Doctor
Phone
+8613681171597
Email
daihongrm@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liping Dou
Phone
+8613681207138
Email
lipingruirui@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daihong Liu Liu, doctor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dai-hong Liu, MD
Phone
86-10-55499036
Ext
86-10-55499036
Email
daihongrm@163.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
We'll reach out to this number within 24 hrs