Acute Myeloid Leukemia, Adult Clinical Trial
Official title:
The Second Affiliated Hospital of Kunming Medical University
This study proposes to conduct a prospective, multicenter, single-arm study to explore the efficacy and safety of venetoclax in combination with high-dose decitabine (DEC3-VEN) in new diagnosed adult patients with AML, and to provide evidence for the optimal selection of clinical treatment regimens, which is planned to be conducted in 10 research centers across the country.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | March 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | Inclusion Criteria: Subjects suitable for enrollment in this study must meet all of the following criteria: 1. meet the World Health Organization diagnostic criteria (WHO2022 criteria) other than APL or carrying one of the abnormal karyotypes such as t(8;21)/(RUNX1::RUNX1TI), inv(16)(p13.1q22), t(16;16) (p13.1q22), t(16;16)/CBFß::myh11), etc. Patients with acute myeloid leukemia other than those with one of the abnormal karyotypes such as t(16;16)/CBFß::myh11 2. Patients with AML not otherwise classified under the World Health Organization AML classification, except for acute myeloproliferative disorder with myelofibrosis and myeloid sarcoma; 3. patients of either sex, age greater than or equal to 16 years and less than 65 years, with a primary diagnosis of AML, who are considered suitable for intensive chemotherapy; 4. Eastern Cooperative Oncology Group (ECOG) physical status = 2 at enrollment; 5. the patient has not received prior treatment for AML (except hydroxyurea and Ara-C <1.0 g/d for tumor composite reduction); 6. passes the following laboratory test markers (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; and serum cardiac enzymes < 2.0 x ULN; unless leukemic organ involvement is considered.2) Creatinine = 30 mL/min, calculated by the Cockcroft Gault formula or measured by 24-hour urine collection 7. Female subjects of childbearing potential must have a negative pregnancy test result within 72 hours prior to the start of treatment; no pregnancy is planned during the study and within 6 months of the last dose of study drug, and a negative urine or serum pregnancy test result at screening. Men must use latex condoms during any sexual contact with WOCBP, even if they have undergone a successful vasectomy, and must agree to avoid childbearing (during treatment and within 6 months of the last dose of study drug); 8. have a life expectancy of more than 2 months; 9. informed consent must be signed prior to the start of all specific study procedures, either by the patient himself/herself or by a member of his/her immediate family; if, in view of the patient's medical condition, his/her own signature would not be conducive to the treatment of his/her medical condition, the informed consent will be signed by his/her legal guardian or by a member of the patient's immediate family. Exclusion Criteria: Subjects may not be enrolled in this study if they meet any of the following criteria: 1. AML with BCR-ABL1; or CML acute stage; 2. Treatment-naïve patients (is defined as having received prior induction chemotherapy regardless of efficacy); 3. Subjects with acute total myelopathy with myelofibrosis or myeloid sarcoma as defined by WHO 2016; 4. Secondary leukemia (primarily those whose World Health Organization (WHO 2016) AML classification falls into the subcategory of treatment-related AML and those with a history of prior MDS and/or MPD); 5. concurrent other hematologic diseases (e.g., hemophilia, myelofibrosis, etc., who are considered unsuitable for enrollment by the investigator; those who have previous blood abnormalities but have ever had bone marrow tests except for MDS and MPD are allowed to be enrolled); 6. Pregnant or lactating patients; 7. Those who are allergic to any drugs involved in this study; 8. Have used strong or moderate CYP7A inducers within 3 days prior to the start of study treatment; 9. concurrent malignant tumors of other organs (those requiring treatment); 10. Significantly abnormal hepatic or renal function beyond the enrollment criteria; 11. Active heart disease, defined as one or more of the following:1) Myocardial infarction less than 6 months from study entry; 2) A history of arrhythmia requiring medication or severe clinical symptoms; 3) Uncontrolled or symptomatic congestive heart failure (> NYHA class 2); 4) Uncontrolled or symptomatic angina;5) Left ventricular ejection fraction below the lower limit of the normal range; 12. severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis), patients with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C; subjects with uncontrolled treatment. 13. Subjects with evidence of central nervous system leukemia prior to treatment; 14. Subjects with epilepsy requiring medication, dementia, or other abnormal mental states that are unable to understand or follow the regimen; 15. Conditions that limit oral drug intake or gastrointestinal absorption; 16. those who, in the opinion of the investigator, are not suitable for enrollment; |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Kunming Medical University. | Kunming | Yunnan |
Lead Sponsor | Collaborator |
---|---|
The Second Affiliated Hospital of Kunming Medical University | Central South University, Chengdu Jingdongfang Hospital, First Affiliated Hospital of Guangxi Medical University, Guizhou Provincial People's Hospital, Handan Central Hospital, Institute of hematology hospital,Chinese Academy of Medical Sciences, Taian City Central Hospital, Tianjin People's Hospital, Western Theater General Hospital |
China,
Del Poeta G, Venditti A, Del Principe MI, Maurillo L, Buccisano F, Tamburini A, Cox MC, Franchi A, Bruno A, Mazzone C, Panetta P, Suppo G, Masi M, Amadori S. Amount of spontaneous apoptosis detected by Bax/Bcl-2 ratio predicts outcome in acute myeloid leukemia (AML). Blood. 2003 Mar 15;101(6):2125-31. doi: 10.1182/blood-2002-06-1714. Epub 2002 Nov 7. — View Citation
Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Dohner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18. — View Citation
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
Pettit K, Odenike O. Defining and Treating Older Adults with Acute Myeloid Leukemia Who Are Ineligible for Intensive Therapies. Front Oncol. 2015 Dec 14;5:280. doi: 10.3389/fonc.2015.00280. eCollection 2015. — 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR | ORR (include CR, CRi, MLFS, PR) of the first course of Venetoclax in combination with high-dose decitabine for the treatment of newly-diagnosed AML adult patients. | up to 24 months | |
Secondary | Overall survival (OS) | defined as the time period from initiation of study medication to death from any cause. | up to 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05133882 -
A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05601726 -
First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients
|
Phase 1 | |
Recruiting |
NCT06200441 -
Correlation of Serum Gasdermin-D and NLRP-3 Inflammasome Levels With GVHD Biomarkers and Endothelial Damage Markers in Graft-Versus-Host Disease
|
||
Recruiting |
NCT04050280 -
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
|
Phase 2 | |
Recruiting |
NCT06449482 -
Selinexor、Venetoclax and Azactidine in the Treatment of ND AML Patients Who Are Not Eligible for Intense Chemotherapy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06252584 -
Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia Patients
|
Phase 1 | |
Completed |
NCT05988047 -
Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia
|
||
Terminated |
NCT03951961 -
Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation
|
Phase 2 | |
Enrolling by invitation |
NCT03902665 -
Up-front Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients Aged 65-75
|
Phase 2 | |
Recruiting |
NCT05127798 -
RWE of 1st Line Treatment in Adults With AML From 18 to 70 Years Old.
|
||
Recruiting |
NCT05906914 -
Cladribine Plus Homoharringtonine and Cytarabine Regimen (CHA) for de Novo Acute Myeloid Leukemia
|
Phase 2 | |
Not yet recruiting |
NCT06199557 -
A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT04752527 -
Individualized Induction Therapy for Non-elderly Acute Myeloid Leukemia Patients With Adverse Risk Features
|
Phase 2 | |
Recruiting |
NCT03766126 -
Lentivirally Redirected CD123 Autologous T Cells in AML
|
Phase 1 | |
Recruiting |
NCT05674539 -
Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome
|
Phase 3 | |
Enrolling by invitation |
NCT02985372 -
Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia
|
Phase 3 | |
Recruiting |
NCT05703126 -
Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With AML
|
N/A | |
Recruiting |
NCT04240600 -
Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital Stay
|
N/A | |
Terminated |
NCT04425655 -
Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.
|
Phase 2 | |
Recruiting |
NCT04454580 -
Hypomethylating Agents and Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy
|