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Trial Title:
Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML
NCT ID:
NCT06429098
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Azacitidine
Decitabine
Venetoclax
Conditions: Keywords:
venetoclax
acute myeloid leukemia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Given PO, once daily. Treatment in cycle 1, the dose is 100 mg on day 1, then ramp up to
400mg. In all subsequent cycles, the dose of venetoclax is initiated at 400 mg daily.
Arm group label:
Venetoclax, Azacitidine/Decitabine/, Cytarabine
Other name:
ABT-199
Other name:
ABT199
Other name:
Venclexta
Intervention type:
Drug
Intervention name:
azacitidine
Description:
Given SC
Arm group label:
Venetoclax, Azacitidine/Decitabine/, Cytarabine
Other name:
5 AZC
Other name:
5-AZC
Intervention type:
Drug
Intervention name:
decitabine
Description:
Given IV
Arm group label:
Venetoclax, Azacitidine/Decitabine/, Cytarabine
Other name:
Dacogen
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Given IV
Arm group label:
Venetoclax, Azacitidine/Decitabine/, Cytarabine
Other name:
1-.beta.-Cytosine arabinoside
Other name:
Ara-C
Summary:
This investigator-initiated, single-arm, phase II trial is aimed to evaluate the efficacy
and safety of a venetoclax-based, anthracycline-free regimen in patients with newly
diagnosed CBFβ::MYH11-positive acute myeloid leukemia.
Detailed description:
Primary Objectives:
To determine the CR (complete remission) / CRi (complete remission with incomplete blood
count recovery) rate of 2 cycles of VEN/HMA in patients with newly diagnosed (ND)
CBFβ::MYH11-positive acute myeloid leukemia(AML).
Secondary Objectives:
1. To determine the overall response rate (ORR) of 2 cycles of VEN/HMA in patients with
ND CBFβ::MYH11-positive AML.
2. To determine the safety of the combination regimen.
3. To study the trajectories of molecular measurable residual disease (MRD) during the
therapy.
4. To evaluate the impact of baseline genomic alterations on response and survival of
the combination regimen.
5. To assess the duration of response, overall survival (OS) and event free survival
(EFS) of patients.
OUTLINE:
INDUCTION:
Patients with newly diagnosed CBFβ::MYH11(+) AML receive 2 cycles of VEN/HMA as induction
therapy. Venetoclax orally (PO) once daily (QD) on days 1-28, azacitidine subcutaneously
(SC) on days 1-7 or decitabine intravenously (IV) over 30-60 minutes on days 1-5.
CONSOLIDATION:
Patient fitness will be reassessed according to the Ferrara criteria if CR or CRi is
achieved after 2 cycles of VEN/HMA. Fit patients will receive four cycles of
consolidation therapy with high-dose cytarabine (2g/m2 every 12 hours, on days 1-3)
combined with venetoclax (on days 1-7). Unfit patients will continue to receive VEN/HMA
until disease progression.
After completion of study treatment, patients are followed up at 30 days and then every 3
months thereafter.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adults ≥ 18 years.
2. Newly diagnosed CBFβ::MYH11(+) AML.
3. Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale.
4. Subject must voluntarily sign and date an informed consent, prior to the initiation
of any screening or study-specific procedures.
Ferrara's criteria are used to determine whether a patient is unfit, and a patient is
deemed unfit if at least one of the following criteria is met:
1. Age>75 years.
2. There are serious underlying heart, lung, kidney, liver complications.
3. There are active infections that do not respond to anti-infective therapy.
4. There is cognitive impairment.
5. Other comorbidities that the doctor determines are not suitable for intensive
chemotherapy.
Exclusion Criteria:
1. Subject has received treatment with a hypomethylating agent and/or other
chemotherapeutic agents either conventional or experimental or targeted drug therapy
for AML (except oral hydroxyurea and/or leukocytometry to reduce white blood cell
count).
2. Pregnant or lactating women.
3. To the knowledge of the subject and investigator, subject may not be able to
complete all study visits or procedures required by the study protocol, including
follow-up visits, and/or be unable to comply with the required study procedures.
4. Other conditions deemed unsuitable for participation in this study by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ethical Committee of the First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou-lin Lu
Phone:
008613914086271
Facility:
Name:
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Wang
Phone:
008613656214782
Email:
wangying77@suda.edu.cn
Start date:
January 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06429098
