Clinical Trials Logo

Clinical Trial Summary

This research is being done to assess the therapeutic efficacy and safety of a promising (venetoclax and decitabine) versus conventional "7+3"chemotherapy in induction young patients with acute myeloid leukemia. This study involves the following: Venetoclax and decitabine (investigational combination) Cytarabine and idarubicin (per standard of care)

Clinical Trial Description

This is an open-label, multicenter, phase Ⅲ randomized clinical trial to compare the therapeutic efficacy and safety of conventional induction chemotherapy (7+3 regimen) to the combination of venetoclax and decitabine among fit, young adults with newly diagnosed acute myeloid leukemia (AML). Conventional induction chemotherapy with idarubicin and cytarabine is the standard of induction chemotherapy for acute myeloid leukemia (AML). The FDA has approved the combination therapy of venetoclax and decitabine for elderly (> 60 year old) patients with newly diagnosed AML not eligible for intensive chemotherapy. Venetoclax is an inhibitor of BCL-2 (B-cell lymphoma 2, a protein that initiates tumor growth, disease progression, and drug resistance), which can lead to cancer cell death. Decitabine, a demethylation agent, has the potential to synergically target leukemia stem cell populations when combined with venetoclax as its homologous drug azacytidine. Participants will be randomly assigned to one of the different induction groups and followed with either consolidated chemotherapy or allogeneic hematopoietic stem cell transplantation after remission. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years. It is expected that about 188 people will take part in this research study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05177731
Study type Interventional
Source The First Affiliated Hospital of Soochow University
Contact Suning Chen
Phone +86-13814881746
Email [email protected]
Status Recruiting
Phase Phase 3
Start date January 1, 2022
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03753542 - Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy N/A
Not yet recruiting NCT05022628 - Clinical Study of Radiotherapy Combined With Donafenib for Neoadjuvant Treatment of Patients With HCC With Portal Vein Carcinoma Thrombosis Phase 4
Recruiting NCT04207359 - Effects of Creatine Supplementation in Breast Cancer Survivors N/A
Recruiting NCT04489173 - TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer Phase 2
Recruiting NCT04874584 - Culturally Tailored Nurse Coaching Study for Cancer Symptom Management N/A
Recruiting NCT04173195 - Comfort Talk (CT) During Outpatient Chemotherapy N/A
Recruiting NCT05014399 - Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Recruiting NCT03275194 - HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy Phase 2
Recruiting NCT04808466 - Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy Phase 2
Not yet recruiting NCT04065139 - Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study Phase 2
Completed NCT04118322 - The Effect of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy N/A
Recruiting NCT04989985 - S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma Phase 2
Not yet recruiting NCT04845490 - Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy Phase 2
Enrolling by invitation NCT04027478 - Can Fasting Decrease the Side Effects of Chemotherapy? N/A
Completed NCT04116138 - Antisecretory Factor in Primary Glioblastoma 1 Phase 1/Phase 2
Recruiting NCT03683407 - Effect of Chemotherapy on TMB in NSCLC
Recruiting NCT04419077 - Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act N/A
Completed NCT03078608 - POEM (Practice Of Embracing Each Moment) STUDY N/A
Recruiting NCT03562234 - The CLiFF Study: Change in Liver Function and Fat in Pre-operative Chemotherapy for Colorectal Liver Metastases
Completed NCT03689478 - Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT N/A