Back to resultsBcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML
Primary Purpose
Acute Myeloid Leukemia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Venetoclax
Azacitidine
Cladribine
Cytarabine
Idarubicin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, Bcl-2 Inhibitors, Azacytidine, Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- The elderly patients(≥ 60) with AML diagnosed according to WHO criteria;
- Participants are ineligible for induction regimen;
- The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3;
- The patients and their families agree and sign the informed consent form.
Exclusion Criteria:
- Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs);
- Infiltration of the central nervous system;
- Drugs use history affecting CYP3A within 7 days before enrollment;
- participants considered by the investigator to be unsuitable for inclusion.
Sites / Locations
- Long ZhaoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Venetoclax group
Arm Description
Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc. Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative. regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2,the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.
Outcomes
Primary Outcome Measures
Overall survival (OS)
Overall survival will be defined as the number of days from the date of first dose to the date of death.
CR/CRi
To assess the percentage of patients achieving CR/CRi according to the International Working Group criteria for AML.
Secondary Outcome Measures
Time to response
To assess the percentage of patients achieving CR/CRi or partial remission (PR) according to the International Working Group criteria for AML.
Duration of response
Duration of response will be defined as the number of days from the date of first response per the IWG criteria for AML to the earliest recurrence or progressive disease.
Mortality
The proportion of patients from enrollment to death was recorded.
Recurrence rate
Record the proportion of patients with recurrence in the study.
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05053425
Brief Title
Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML
Official Title
Clinical Study of Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
January 18, 2023 (Anticipated)
Study Completion Date
March 18, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LanZhou University
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.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this prospective study, 30 newly untreated elderly patients with acute myeloid leukemia(AML) who were not suitable for standard chemotherapy were enrolled to observe the efficacy and side effects of venetoclax (VEN) combined with azacytidine (AZA) and chemotherapy in newly treated elderly patients with AML. Overall survival (OS), complete remission rate/complete remission with incomplete recovery of blood cell count (CR/ CRi) were used as the primary endpoints, and time to response (TTR), duration of response (DOR), mortality, and recurrence rate were used as secondary endpoints,and the incidence of adverse events were evaluated.
Detailed Description
Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc. Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative.
regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2, the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia, Bcl-2 Inhibitors, Azacytidine, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Venetoclax group
Arm Type
Experimental
Arm Description
Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc.
Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative.
regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2,the reduction of regimen IA(cytarabine+idarubicin)was 5+2.
Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199
Intervention Description
given po.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
5-Azacytidine
Intervention Description
given sc.
Intervention Type
Drug
Intervention Name(s)
Cladribine
Other Intervention Name(s)
2-CdA
Intervention Description
given ivgtt.
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Ara-c
Intervention Description
given sc or ivgtt.
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Other Intervention Name(s)
Idamycin®
Intervention Description
given ivgtt.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival will be defined as the number of days from the date of first dose to the date of death.
Time Frame
up to 16 months.
Title
CR/CRi
Description
To assess the percentage of patients achieving CR/CRi according to the International Working Group criteria for AML.
Time Frame
up to 16 months.
Secondary Outcome Measure Information:
Title
Time to response
Description
To assess the percentage of patients achieving CR/CRi or partial remission (PR) according to the International Working Group criteria for AML.
Time Frame
up to 16 months.
Title
Duration of response
Description
Duration of response will be defined as the number of days from the date of first response per the IWG criteria for AML to the earliest recurrence or progressive disease.
Time Frame
up to 16 months.
Title
Mortality
Description
The proportion of patients from enrollment to death was recorded.
Time Frame
up to 16 months.
Title
Recurrence rate
Description
Record the proportion of patients with recurrence in the study.
Time Frame
up to 16 months.
Title
Adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
Adverse events were assessed weekly during the first and second cycles, and every two cycles thereafter (each cycle is 28 days), up to 16 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The elderly patients(≥ 60) with AML diagnosed according to WHO criteria;
Participants are ineligible for induction regimen;
The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3;
The patients and their families agree and sign the informed consent form.
Exclusion Criteria:
Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs);
Infiltration of the central nervous system;
Drugs use history affecting CYP3A within 7 days before enrollment;
participants considered by the investigator to be unsuitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long Zhao, M.M.
Phone
+18919128021
Email
zhaodragon@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long Zhao, M.M.
Organizational Affiliation
The First Hospital of Lanzhou University,Lanzhou,Gansu,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Zhao
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Long Zhao
Phone
+18919128021
Email
zhaodragon@126.com
First Name & Middle Initial & Last Name & Degree
Qiushan Li
Phone
+8613893690080
Email
ldyylwh@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML
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