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This is a prospective phase II, single-arm clinical study that plans to enroll 45 patients aged 60 years or older with primary AML diagnosed after April 1, 2023.The purpose of this trial is to evaluate the efficacy of Venetoclax in combination with azacitidine and HA regimens in elderly patients aged >60 years with primary acute myeloid leukemia and to provide evidence for optimal selection of clinical treatment regimens.
Full description
Patients diagnosed with primary AML according to morphology, immunophenotyping and medical history and meeting the exclusion criteria for enrollment: induction therapy with Venetoclax combined with azacitidine and HA regimen, after induction therapy up to CR, CRi, MLFS, according to ELN prognostic stratification and NCCN and Chinese guidelines for the treatment of adult AML (non-acute promyelocytic leukemia), according to patient risk stratification and treatment For patients with allogeneic hematopoietic stem cell transplantation due to various reasons (financial, physical, and other reasons), the patient will be recommended for transplantation. Patients who are not considered for allogeneic HSCT due to various reasons (financial, physical, donor constraints, etc.) will continue to receive two courses of intensive treatment with Venetoclax combined with a medium-dose Ara-c regimen and three courses of reduced-dose chemotherapy for consolidation. Patients completing intensive consolidation therapy enter maintenance treatment with Venetoclax in combination with azacitidine, danazol and thalidomide. Patients who do not achieve CR, CRi and MLFS with 1 course of induction therapy will be re-induced with the original regimen if they achieve PR. Patients who did not achieve PR on the first induction treatment and did not achieve CR, CRi, and MLFS after two induction treatments were dropped from the group and given salvage therapy. Patients with persistent positive MRD or recurrence during treatment were withdrawn from the group and given salvage therapy.
Enrollment
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Inclusion criteria
Exclusion criteria
1、Treated patients (is defined as having received induction chemotherapy in the past, regardless of the efficacy).
2, Concurrent malignant tumors of other organs (those requiring treatment). 3, Patients participating in the trial must use contraception during the trial treatment and within 3 years after completion of treatment.
4, Significantly abnormal liver and kidney function beyond the enrollment criteria.
Active heart disease, defined as one or more of the following:
History of uncontrolled or symptomatic angina;
Myocardial infarction less than 6 months from study entry;
A history of arrhythmia requiring medication or clinically significant symptoms;
Uncontrolled or symptomatic congestive heart failure (> NYHA class 2);
Ejection fraction below the lower limit of the normal range. 6. severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis).
Primary purpose
Allocation
Interventional model
Masking
45 participants in 1 patient group
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Central trial contact
yaxian tan
Data sourced from clinicaltrials.gov
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