Clinical Study Protocol for the Treatment of Newly Diagnosed and Relapsed/Refractory Acute Myeloid Leukemia With KMT2A Gene Abnormalities Using VHEA(Venetoclax With Homoharringtonine,Etoposide,Cytarabine)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA(Venetoclax with Homoharringtonine,Etoposide,Cytarabine)regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities. This study includes the induction and consolidation phases of AML treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Age between 18 and 60 years old;Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• Expected survival time of at least 3 months.

• Does not meet any of the following criteria for severe heart, lung, liver, or kidney disease:A) History of congestive heart failure requiring treatment, or ejection fraction ≤ 50%, or presence of chronic stable angina;B) Lung diffusing capacity for carbon monoxide (DLCO) ≤ 65%, or forced expiratory volume in one second (FEV1) ≤ 65%;C) Moderate liver dysfunction, total bilirubin \> 1.5 to ≤ 3.0 × upper limit of normal (ULN);D) Creatinine clearance ≥ 30 mL/min to \< 45 mL/min.

• No other significant contraindications to chemotherapy as determined by the physician;

• Capable of understanding and willing to sign the informed consent form for this study.

Locations
Other Locations
China
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University(Huai'an First People's Hospital)
RECRUITING
Huai'an
Contact Information
Primary
Shandong Tao
TSD8884@126.com
15252393900
Time Frame
Start Date: 2022-05-24
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 34
Treatments
Experimental: VHEA regimen in the treatment of ND-AML and RR-AML with MLL gene abnormalities.
Venetoclax 100 mg d1,200 mg d2,400 mg d3-14; homoharringtoine, HHT 2 mg/m2,qd,d1-7; Etoposide 0.1 g,qd,d1-5; Cytarabine 100 mg/m2,qd,d1-7~The patient meets the criteria for autologous hematopoietic stem cell transplantation (ASCT) during the treatment process, they can undergo ASCT.If the patient meets the criteria for transplantation and there is a suitable donor, they can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Hospital of Xuzhou Medical University, The First People's Hospital of Changzhou, Zhenjiang First People's Hospital
Leads: Huai'an First People's Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials