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Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients

Primary Purpose

Leukemia, Myeloid, Acute

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Azacitidine

Venetoclax

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Acute Myeloid Leukemia, Newly Diagnosed AML, Azacitidine, Venetoclax, Induction Therapy

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.Age 45 to 65 years old,both male and female
2.Be able to understand and sign informed consent
3.Untreated AML patients (non-APL) diagnosed according to the 2016 World Health Organization (WHO) classification and diagnostic criteria for acute myeloid leukemia
4.Patients with an ECOG performance status 0,1,2 or 3
5.Expected survival time≥3 months
6.Laboratory indicators meet the following standards:
1. Bilrubin, ALT and AST were all less than 3 times the upper limit of normal within 7 days before the first day of treatment
2. Serum creatinine clearance rate is greater than 30ml/min

Exclusion Criteria:

1.patients participating in other interventional or observational clinical studies currently
2.Patients has a history of myeloproliferative neoplasm [MPN]
3.Patients with acute promyelocytic leukemia
4.Active CNS involvement in patients with acute myeloid leukemia
5.Patients with active hepatitis B or C, HIV infection before enrollment
6.Cardiovascular status of patients evaluate by NYHA classification method > 2
7.Patients have chronic respiratory disease requiring continuous oxygen treatment, or any sitiuation investigator believes will adversely affect this study (including renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease and known history of allergy to any study drug)
8.Patients suffering from malabsorption syndrome or other diseases that prevent the enteral route of administration
9.patients present with an uncontrolled systemic infection (viral, bacterial, or fungal)
10.Patients with a history of other malignancies within 2 years before enrollment, except for the following cases:
1. Adequately treated carcinoma in situ of the cervix or carcinoma of the breast
2. Basal cell carcinoma or localized squamous cell carcinoma of skin

Sites / Locations

Nanfang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Azacitidine combined with Venetoclax

Arm Description

Each course is 28 days long. Subjects with newly diagnosed AML receive Venetoclax once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. If concomitantly receiving azoles, the dose of Venetoclax will be adjusted according to the instructions. At the same time patients will receive Azacitidine 75mg/m2 subcutaneous on Days 1-7.The induction therapy includes 1-2 cycle until subjects get remission. Once complete remission, subjects will receive consolidation. Azacitidine combined with Venetoclax or middle to high dose of arabinoside based chemotherapy would be given at the discretion of the physician.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)

ORR is defined as the percentage of participants who achieve the CR + CRi + Partial Remission (PR) as evaluated by the investigator.

Secondary Outcome Measures

Minimal residual disease (MRD) negative response rate

The number of subjects who obtained MRD negative as a percentage of all evaluable subjects.

Duration of Remission (DOR)

From the first achievement of PR, CR, or CRi to time of disease progression

Allogeneic Hematopoietic Stem Cell Transplantation Rate

Proportion of subsequent allogeneic hematopoietic stem cell transplantation in intermediate-risk and adverse-risk patients

Overall Survival (OS)

From start of protocol treatment to time of death due to any cause, or until last follow-up

Event-Free Survival (EFS)

From start of protocol treatment to time of disease relapse/progression or death due to any cause, whichever occurs earlier; or until last follow-up

Full Information

NCT ID

NCT05471700

First Posted

July 1, 2022

Last Updated

October 9, 2023

Sponsor

Zhujiang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05471700

Brief Title

Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients

Official Title

To Evaluate Safety and Efficacy of Azacitidine Combination With Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients：A Multicenter, Single-arm Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2022 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this clinical research study is to evaluate the safety and efficacy of Azacytidine in combination with Venetoclax in patients with newly diagnosed fit acute myeloid leukemia.

Detailed Description

The Study Drug: Azacitidine is a DNA Demethylated drug, which is approvd for treatment of elderly AML patients Venetoclax targets the anti-apoptotic protein Bcl-2 and the process of oxidative phosphorylation to induce apoptosis of leukemia cells and exhibits anti-tumor activity. Study Group: single arm: AZA plus Venetoclax Study Drug Administration: Each course is 28 days long. Venetoclax is taken once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. If concomitantly receiving azoles, the dose of Venetoclax will be adjusted according to the instructions. Azacitidine is taken 75mg/m2 on Days 1-7. Subjects would received 1-2 cycles induction therapy. Once get remission, subjects would received the same indution therapy of middle to high dose of cytarabine based chemotherapy at the discretion of the physician for consolidation. Allo-HSCT is suggested for subjects with the moderate to adverse ELN2017 risk. Study Visit: After treatment, relapse and survival will be followed monthly by telephone, on-site visits, and/or study medical records for up to two years (calculated from the first day of induction therapy); Thereafter follow-up every 3 months for one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myeloid, Acute

Keywords

Acute Myeloid Leukemia, Newly Diagnosed AML, Azacitidine, Venetoclax, Induction Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Azacitidine combined with Venetoclax

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Other Intervention Name(s)

5-Azacitidine, 5-aza

Intervention Description

Subjects will receive Azacitidine 75 mg/m2 on days 1-7.Each course is 28 days long.

Intervention Type

Drug

Intervention Name(s)

Venetoclax

Other Intervention Name(s)

Venclexta, Venclyxto

Intervention Description

Subjects would receive Venetoclax once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. Each course is 28 days long.

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR)

Description

ORR is defined as the percentage of participants who achieve the CR + CRi + Partial Remission (PR) as evaluated by the investigator.

Time Frame

Up to 36 months

Secondary Outcome Measure Information:

Title

Minimal residual disease (MRD) negative response rate

Description

The number of subjects who obtained MRD negative as a percentage of all evaluable subjects.

Time Frame

Up to 36 months

Title

Duration of Remission (DOR)

Description

From the first achievement of PR, CR, or CRi to time of disease progression

Time Frame

Up to 36 months

Title

Allogeneic Hematopoietic Stem Cell Transplantation Rate

Description

Proportion of subsequent allogeneic hematopoietic stem cell transplantation in intermediate-risk and adverse-risk patients

Time Frame

Up to 36 months

Title

Overall Survival (OS)

Description

From start of protocol treatment to time of death due to any cause, or until last follow-up

Time Frame

Up to 36 months

Title

Event-Free Survival (EFS)

Description

From start of protocol treatment to time of disease relapse/progression or death due to any cause, whichever occurs earlier; or until last follow-up

Time Frame

Up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1.Age 45 to 65 years old,both male and female 2.Be able to understand and sign informed consent 3.Untreated AML patients (non-APL) diagnosed according to the 2016 World Health Organization (WHO) classification and diagnostic criteria for acute myeloid leukemia 4.Patients with an ECOG performance status 0,1,2 or 3 5.Expected survival time≥3 months 6.Laboratory indicators meet the following standards: Bilrubin, ALT and AST were all less than 3 times the upper limit of normal within 7 days before the first day of treatment Serum creatinine clearance rate is greater than 30ml/min Exclusion Criteria: 1.patients participating in other interventional or observational clinical studies currently 2.Patients has a history of myeloproliferative neoplasm [MPN] 3.Patients with acute promyelocytic leukemia 4.Active CNS involvement in patients with acute myeloid leukemia 5.Patients with active hepatitis B or C, HIV infection before enrollment 6.Cardiovascular status of patients evaluate by NYHA classification method > 2 7.Patients have chronic respiratory disease requiring continuous oxygen treatment, or any sitiuation investigator believes will adversely affect this study (including renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease and known history of allergy to any study drug) 8.Patients suffering from malabsorption syndrome or other diseases that prevent the enteral route of administration 9.patients present with an uncontrolled systemic infection (viral, bacterial, or fungal) 10.Patients with a history of other malignancies within 2 years before enrollment, except for the following cases: Adequately treated carcinoma in situ of the cervix or carcinoma of the breast Basal cell carcinoma or localized squamous cell carcinoma of skin

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huang Rui, Doctor

Phone

+8615918528317

Rachelchn@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaonan Lin, Bachelor

Phone

+8619915233632

2381215788@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuhua Li, Doctor

Organizational Affiliation

Zhujiang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nanfang Hospital of Southern Medical University

City

Guanzhou

State/Province

Guandong

ZIP/Postal Code

510250

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rui Huang, Doctor

Phone

+8615918528317

Rachelchn@163.com

First Name & Middle Initial & Last Name & Degree

Yunqing Wang, Bachelor

Phone

+8618585509970

Wangyun7q@163.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We will share our data within 6 months after the end of the trial. You can ask us for data or obtain it on the Clinical Trial Management Public Platfcrm of clinical trial. Supporting Information: Study Protocol

IPD Sharing Time Frame

The data will be available and permanently disclosed within 6 months after the trial.

IPD Sharing Access Criteria

You can log in to the website for data access or contact us for data.

Learn more about this trial

Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients

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