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Trial Title:
A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia
NCT ID:
NCT06387420
Condition:
ACUTE MYELOID LEUKEMIA; AML
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
AK117
Description:
Subjects receive AK117 intravenously.
Arm group label:
AK117+Azacitidine+Venetoclax
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Subjects receive azacitidine subcutaneously.
Arm group label:
AK117+Azacitidine+Venetoclax
Arm group label:
Placebo+Azacitidine+Venetoclax
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Subjects receive venetoclax orally.
Arm group label:
AK117+Azacitidine+Venetoclax
Arm group label:
Placebo+Azacitidine+Venetoclax
Intervention type:
Other
Intervention name:
Placebo
Description:
Subjects receive placebo intravenously.
Arm group label:
Placebo+Azacitidine+Venetoclax
Summary:
This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML),
Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this
study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in
subjects with AML.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 years old at the time of enrolment.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0~3, and 0~2
are required for subjects ≥75 years old.
- Has a life expectancy of at least 12 weeks.
- Diagnosed as AML diagnosed according to WHO 2022 criteria.
- Has adequate organ function.
- All female and male subjects of reproductive potential must agree to use an
effective method of contraception, as determined by the Investigator, during and for
120 days after the last dose of study treatment.
Exclusion Criteria:
- Diagnosed with acute promyelocytic leukemia, BCR-ABL1-positive AML, myeloid sarcoma,
mixed phenotype acute leukemia (MPAL), accelerated phase or blast crisis of Chronic
Myeloid Leukemia.
- has central nervous system leukemia (CNSL).
- Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per
the National Comprehensive Cancer Network (NCCN) Guidelines Version 6, 2023 for AML.
- Previously diagnosed with another malignancy or have any evidence of residual
disease.
- Previous allogeneic hematopoietic stem cell transplant (allo-HSCT).
- Prior treatment with any B-cell lymphoma 2 (Bcl-2) inhibitors, anti-CD47 or
anti-SIRPα (signal regulatory protein alpha) agent.
- Use strong or moderate cytochrome P450 (CYP) 3A inducers systemically within one
week prior to enrollment, or currently require long-term treatment with a moderate
to strong CYP3A inducer.
- Previously diagnosed with MDS and treated with demethylating drugs.
- Patients with known cardiopulmonary disease defined as unstable angina, clinically
significant arrhythmia, congestive heart failure (New York Heart Association Class
III or IV), decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic
disorders.
- Other conditions where the investigator considers the patient inappropriate for
enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Address:
City:
Tianjin
Country:
China
Contact:
Last name:
Jianxiang Wang
Start date:
April 29, 2024
Completion date:
April 2027
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06387420
