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AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

Primary Purpose

Acute Myeloid Leukemia (AML) in Remission

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Azacitidine
Venetoclax
Supportive care
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) in Remission

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not immediate candidates for allogeneic stem cell transplant.
  2. Aged 18-64 years.
  3. Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.
  4. ECOG performance status of < or = 3.

  5. Adequate organ function as follows:

    1. Serum total bilirubin < or = to 3 X the Upper Limit of Normal (ULN)
    2. Aspartate Transaminase and alanine transaminase < or = to 3 x ULN
    3. Ccr（Creatinine Clearance Rate) > or ＝60 ml/min
    4. Left ventricular ejection fraction > or ＝50% determined by ultrasound.
  6. For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.
  7. For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
  8. Ability to understand and sign informed consent.

Exclusion Criteria:

  1. Acute promyeloid leukemia.
  2. Patients with active central nervous system (CNS) leukemia.
  3. Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
  4. Patients with other progressive malignancies.
  5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
  6. Patients who have participated in other trials within 30 days before signing the informed consent.
  7. Females who are pregnant or lactating or intending to become pregnant during the study.

Sites / Locations

  • First Affiliated Hospital of Soochow UniversityRecruiting
  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of HematologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment (azacytidine+venetoclax)

Comparator ( best supportive care)

Arm Description

Participants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles.

Participants will receive observation and supportive care during remission.

Outcomes

Primary Outcome Measures

Relapse-free survival (RFS)
RFS is defined as the number of days from CR/CRi to the date of relapse or the date of death from any cause, whichever comes first.

Secondary Outcome Measures

Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion
The MRD conversion rate is defined as the percentage of participants deemed MRD positive (≥ 10^-3) at study initiation who converted to MRD of < 10^-3 in the bone marrow after randomization or initiation of treatment.
Complete remission duration (CRd)
CRd is defined as time from CR/CRi until date of confirmed relapse
Overall Survival (OS)
OS is defined as the number of days from the date of study treatment to the date of death.
Event free survival (EFS)
EFS is defined as time from the start of study treatment until date of first confirmed relapse, withdrawal from study due to adverse event, or death due to any cause,
Incidence of adverse events
The NCI Common Toxicity Criteria (CTCAE 5.0) is used to grade adverse events.

Full Information

First Posted
May 31, 2022
Last Updated
August 18, 2022
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05404906
Brief Title
AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
Official Title
Randomized, Multicenter, Phase 3 Study of Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remissionin Younger Adults With Favorable-risk AML in First Remission After Conventional Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2022 (Actual)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow 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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML) in Remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (azacytidine+venetoclax)
Arm Type
Experimental
Arm Description
Participants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles.
Arm Title
Comparator ( best supportive care)
Arm Type
Experimental
Arm Description
Participants will receive observation and supportive care during remission.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
5-Azacytidine
Intervention Description
Given SC
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, GDC-0199, Venclexta
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Supportive care
Intervention Description
Patients will receive disease monitoring and supportive care for any complication.
Primary Outcome Measure Information:
Title
Relapse-free survival (RFS)
Description
RFS is defined as the number of days from CR/CRi to the date of relapse or the date of death from any cause, whichever comes first.
Time Frame
From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion
Description
The MRD conversion rate is defined as the percentage of participants deemed MRD positive (≥ 10^-3) at study initiation who converted to MRD of < 10^-3 in the bone marrow after randomization or initiation of treatment.
Time Frame
Measured From Baseline to approximately 3 years
Title
Complete remission duration (CRd)
Description
CRd is defined as time from CR/CRi until date of confirmed relapse
Time Frame
From date of CR/CRi to approximately 3 years
Title
Overall Survival (OS)
Description
OS is defined as the number of days from the date of study treatment to the date of death.
Time Frame
Time from treatment to death from any cause, up to approximately 3 years
Title
Event free survival (EFS)
Description
EFS is defined as time from the start of study treatment until date of first confirmed relapse, withdrawal from study due to adverse event, or death due to any cause,
Time Frame
Time from treatment to relapse，withdrawal from study due to adverse event and death from any cause, up to approximately 3 years
Title
Incidence of adverse events
Description
The NCI Common Toxicity Criteria (CTCAE 5.0) is used to grade adverse events.
Time Frame
Time from treatment to approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not immediate candidates for allogeneic stem cell transplant. Aged 18-64 years. Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission. ECOG performance status of < or = 3. Adequate organ function as follows: Serum total bilirubin < or = to 3 X the Upper Limit of Normal (ULN) Aspartate Transaminase and alanine transaminase < or = to 3 x ULN Ccr（Creatinine Clearance Rate) > or ＝60 ml/min Left ventricular ejection fraction > or ＝50% determined by ultrasound. For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling. For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment. Ability to understand and sign informed consent. Exclusion Criteria: Acute promyeloid leukemia. Patients with active central nervous system (CNS) leukemia. Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML. Patients with other progressive malignancies. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal). Patients who have participated in other trials within 30 days before signing the informed consent. Females who are pregnant or lactating or intending to become pregnant during the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suning Chen
Phone
+86-13814881746
Email
chensuning@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suning Chen
Organizational Affiliation
First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suning Chen, PhD
Phone
+8613814881746
Email
chensuning@sina.com
Facility Name
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suning Chen, Professor
Phone
13814881746
Email
chensuning@sina.com
First Name & Middle Initial & Last Name & Degree
Suning Chen, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

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AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

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