Acute Myeloid Leukemia Clinical Trial
Official title:
The Second Affiliated Hospital of Kunming Medical University
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: 1. patients with acute myeloid leukemia other than APL who meet the World Health Organization diagnostic criteria (WHO 2016 criteria); 2. those with AML not otherwise classified under the World Health Organization AML classification except for acute myeloproliferative disorder with myelofibrosis and myeloid sarcoma. 3. Age > 60 years, male or female. 4. Have a score of 0-2 on the Eastern Cooperative Oncology Group Physical Status Scale (ECOG-PS). 5. pass the requirements of the following laboratory test indicators (performed within 7 days prior to treatment): 1) Aspartate aminotransferase (ALT), alanine aminotransferase (AST), and alkaline phosphatase (ALP) = 3 x upper limit of normal (ULN), serum bilirubin = 2 x ULN; serum cardiac enzymes < 2.0 x ULN; serum creatinine = 2.0 x ULN; 2) Cardiac ejection fraction within normal values as determined by cardiac ultrasound (ECHO). 6. Informed consent had to be signed before all specific study procedures were started, and the informed consent was signed by the patient himself/herself or his/her immediate family members; in view of the patient's condition, if the signature of the patient himself/herself was not conducive to the treatment of his/her condition, the informed consent was signed by his/her legal guardian or the patient's immediate family members. 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. 5. Active heart disease, defined as one or more of the following: 1. History of uncontrolled or symptomatic angina; 2. Myocardial infarction less than 6 months from study entry; 3. A history of arrhythmia requiring medication or clinically significant symptoms; 4. Uncontrolled or symptomatic congestive heart failure (> NYHA class 2); 5. Ejection fraction below the lower limit of the normal range. 6. severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis). 7) Those deemed unsuitable for enrollment by the investigator |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Kunming Medical University. | Kunming | Yunnan |
Lead Sponsor | Collaborator |
---|---|
ZePing Zhou | Guizhou Provincial People's Hospital, Handan Central Hospital, Second Xiangya Hospital of Central South University, Taian City Central Hospital, Tianjin People's Hospital, Western War Zone General Hospital |
China,
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DiNardo CD, Lachowiez CA, Takahashi K, Loghavi S, Xiao L, Kadia T, Daver N, Adeoti M, Short NJ, Sasaki K, Wang S, Borthakur G, Issa G, Maiti A, Alvarado Y, Pemmaraju N, Montalban Bravo G, Masarova L, Yilmaz M, Jain N, Andreeff M, Jabbour E, Garcia-Manero G, Kornblau S, Ravandi F, Konopleva MY, Kantarjian HM. Venetoclax Combined With FLAG-IDA Induction and Consolidation in Newly Diagnosed and Relapsed or Refractory Acute Myeloid Leukemia. J Clin Oncol. 2021 Sep 1;39(25):2768-2778. doi: 10.1200/JCO.20.03736. Epub 2021 May 27. — View Citation
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Mei M, Aldoss I, Marcucci G, Pullarkat V. Hypomethylating agents in combination with venetoclax for acute myeloid leukemia: Update on clinical trial data and practical considerations for use. Am J Hematol. 2019 Mar;94(3):358-362. doi: 10.1002/ajh.25369. Epub 2018 Dec 13. — View Citation
Wei AH, Strickland SA Jr, Hou JZ, Fiedler W, Lin TL, Walter RB, Enjeti A, Tiong IS, Savona M, Lee S, Chyla B, Popovic R, Salem AH, Agarwal S, Xu T, Fakouhi KM, Humerickhouse R, Hong WJ, Hayslip J, Roboz GJ. Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study. J Clin Oncol. 2019 May 20;37(15):1277-1284. doi: 10.1200/JCO.18.01600. Epub 2019 Mar 20. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall response rate (ORR) | which evaluates the efficacy of patient induction therapy, including complete remission (CR), complete remission with incomplete blood count recovery (CRi), and morphologic leukemia-free state (MLFS) | up to 12 months | |
Secondary | Minimal residual disease (MRD) | MRD percentage | up to 12 months | |
Secondary | overall survival (OS) | Overall Survival (OS) is used to evaluate all patients enrolled in a clinical trial, from the date of enrollment until death from any cause or the date of last follow-up for surviving patients. | up to 12 months | |
Secondary | relapse-free survival (RFS) | Relapse-Free Survival (RFS) is only used to evaluate patients who achieve complete remission (CR) through reinduction therapy. RFS is defined as the time from achievement of CR until death from any cause, relapse, or the date of last follow-up. | up to 12 months | |
Secondary | 30-day mortality rate | The 30-day mortality rate is used to evaluate all patients enrolled in a clinical trial, and is defined as the percentage of patients who die within 30 days of starting chemotherapy. | Within 30 days after starting the medication | |
Secondary | adverse drug reactions | Adverse drug reactions during chemotherapy and follow-up | up to 12 months |
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