Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04752527
Other study ID # SZ-AML01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 20, 2021
Est. completion date December 2022

Study information

Verified date February 2021
Source The First Affiliated Hospital of Soochow University
Contact suning chen, professor
Phone 8613814881746
Email chensuning@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Individualized induction therapy will be applied to the non-elderly acute myeloid leukemia (AML) patients with adverse genetic risk features guided by rapid screening with fluorescence in situ hybridization (FISH) and next-generation sequencing (NGS), such as the combination of Venetoclax plus decitabine, and Sorafenib for patients with high (FMS)-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) allelic ratio. This study aims to improve induction therapy for non-elderly AML patients with adverse genetic risk features, reduce treatment-related complications, and improve overall survival.


Description:

The non-elderly AML patients who meet the adverse risk group defined as 2017 European LeukemiaNet (ELN) risk stratification, are more likely to be refractory to intensive induction and have low rates of long-term survival. Venetoclax (drug name) plus decitabine or azacitidine showed tolerable safety and favorable overall response rate (ORR )(complete remission (CR)+CR with incomplete hematologic recovery (CRi) rate: 67%) in elderly AML patients. In addition, combination therapy with sorafenib, cytarabine and idarubicin was able to induce a high CR rate in non-elderly AML patients with FLT3 mutations and a 1-year probability of survival of 74%. The fast next-generation sequencing together with FISH can identify the adverse genetic risk features in AML patients within 72 hours. Individualized induction therapy will be applied to the non-elderly AML patients with adverse genetic risk features guided by rapid screening with FISH and NGS, such as the combination of venetoclax plus decitabine, and Sorafenib for patients with high FLT3-ITD allelic ratio. This study aims to improve induction therapy for non-elderly AML patients with adverse genetic risk features, reduce treatment-related complications, and improve overall survival.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria: 1. Male or female, 59 > =Age (years) >= 18; 2. Newly diagnosed as AML patients according to World Health Organization (WHO) classification; 3. AML patients meet the adverse risk group according to 2017 European Leukemia Net risk stratification; 4. Patients have not received prior therapy for AML (except HU); 5. Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ; 6. Liver function: Total bilirubin ?3 upper limit of normal (ULN); aspartate aminotransferase (AST) ?3 ULN; alanine aminotransferase (ALT)?3 ULN(except extramedullary infiltration of leukemia) 7. Renal function:Ccr ?30 ml/min; 8. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent. Exclusion Criteria: 1. Acute promyeloid leukemia; 2. AML with central nervous system (CNS) infiltration; 3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML; 4. HIV infection; 5. Patients with severe heart failure (grade 3-4) ; 6. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Uncontrolled and/or active systemic infection (viral, bacterial or fungal); b) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. c)An active second cancer that requires treatment within 6 months of study entry 7. Patients deemed unsuitable for enrolment by the investigator; 8. Patients willing to receive intensive induction chemotherapy 9. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen; 10. Patients reject to participate in the study.

Study Design


Intervention

Drug:
venetoclax combined with decitabine
combination of venetoclax plus decitabine, and sorafenib for patients with high FLT3-ITD allelic ratio. (On day 1 of cycle 1, decitabine 20 mg/m2 will be given intravenously, and will continue for 5 days. Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 28 day cycle is finished. For patients with high FLT3-ITD allelic ratio, sorafenib was administered at a dose of 400mg orally twice daily, on days 3 through 28.

Locations

Country Name City State
China The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology Suzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CR/CRi/morphologic leukemia free state (MLFS) Complete remission/complete remission with incomplete count recovery/Morphologic Leukemia Free State(after one cycle or two cycles of induction therapy) Study start date to study end date, or death, whichever comes first, up to 4 years
Secondary Event Free Survival(EFS) Event Free Survival Study start date to study end date, or death, whichever comes first, up to 4 years
Secondary Overall Survival(OS) Overall Survival Study start date to study end date, or death, whichever comes first, up to 4 years
Secondary Incidence of Adverse Events infection, blood transfusion, and other toxicity Study start date to study end date, or death, whichever comes first, up to 4 years
See also
  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
Not yet recruiting NCT06285136 - Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult Phase 2/Phase 3
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 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