RecruitingPhase 2NCT06451861
Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML
Randomized Study of ABC-14 Regimen ( AZA, Venetoclax and Chidamide) Compared With "3+7" Standard Induction Therapy or AB-14 (Venetoclax Combined With Azacitidine) for Newly Diagnosed Acute Myeloid Leukemia
Sponsor
Guangdong Provincial People's Hospital
Enrollment
240 participants
Start Date
Aug 21, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine and other tumor reduction pretreatments);
- Age ≥18 years old;
- ECOG≤4;
- The fertile woman agrees to use effective contraception during the treatment period and up to 3 months after the end of the treatment; Sign the informed consent form.
Exclusion Criteria6
- Known history of allergy to the investigational drug;
- Resistance to azacytidine, azacitidine, Venetoclax;
- Inability to take oral medication;
- Combined with uncontrolled active infections (including bacterial, fungal or viral infections);
- Combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.;
- Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.
Interventions
DRUGChidamide
Induction Therapy
DRUGVenetoclax
Induction Therapy
DRUGazacitidine
Induction Therapy
DRUGAnthracyclines or anthraquinones
Induction Therapy
DRUGcytarabine
Induction Therapy
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT06451861
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