Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy

Acute Myeloid Leukemia Clinical Trial

Official title:

Optimizing Induction Chemotherapy Regimens for Newly Diagnosed Elderly Acute Myeloid Leukemia Patients Who Are Eligible for Intense Chemotherapy: A Multicenter, Randomized, Controlled Phase II Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06066242
• Other study ID #: IIT2023059-EC-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: October 10, 2025

Study information

• Verified date: September 2023
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: Hui Wei, MD
• Phone: 86-022-23909020
• Email: weihui[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of three different induction regimens (Ven+AZA vs DA/IA 3+7 vs DA/IA 2+5+VEN). A total of 90 patients will be enrolled in this study and segregated into thress groups with 30 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 10, 2025
• Est. primary completion date: October 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Able to understand the study and voluntarily sign informed consent.

2. Age: 60~75 years old, gender unlimited.

3. Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated.

4. Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2.

5. Fit for intensive chemotherapy.

6. The function of main organs should meet the following standards before treatment:

Kidney: serum creatinine = 2× upper limit of normal range (ULN); Liver: total bilirubin = 1.5 × ULN, AST and ALT = 2.5× ULN; Heart: myocardial enzymes = 2× ULN and normal ejection fraction by cardiac color doppler ultrasound

Exclusion Criteria:

1. Patients with acute promyelocytic leukemia

2. Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene

3. Patients with BCR::ABL fusion gene

4. Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before.

5. Patients with concurrent malignant tumors requiring treatment

6. Patients with active heart disease defined as one or more of the following: (1) Uncontrolled or symptomatic angina pectoris;(2) A myocardial infarction 6 months before enrolled; (3)Arrhythmia needed medication or with severe clinical symptoms;(4)Uncontrolled or symptomatic congestive heart failure (NYHA> grade 2);(5)Left ventricular ejection fraction below the lower limit of the normal range.

7. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Different induction chemotherapy regimens
azacitidine combined with venetoclax or chemotherapy with or without venetoclax

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival (EFS)	It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).	Up to approximately 2 years
Secondary	Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate	Proportion of patients with CR, CRh or CRi	Up to approximately eight weeks
Secondary	Minimal residual disease (MRD)-negative remission rates after induction	Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative	Up to approximately eight weeks
Secondary	Cumulative incidence of minimal residual disease (MRD)-negative remission rates	The proportion of patients with negative MRD results at any time during treatment	Up to approximately 1 years
Secondary	Relapse-free Survival (RFS)	It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up.	Up to approximately 2 years
Secondary	Overall survival (OS)	It is defined as the time from the start of randomization to the death from any cause.	Up to approximately 2 years
Secondary	30-day postinduction mortality	It is defined as death from any cause within 30 days after the start of induction.	Up to approximately 30 days
Secondary	60-day postinduction mortality	It is defined as death from any cause within 60 days after the start of induction.	Up to approximately 60 days