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

Not Applicable

Recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Other: Different induction chemotherapy regimens

• Registration Number: NCT06066242
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-09-27
• Study Start: 2023-10-01
• Study First Posted: 2023-10-04
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-10-10
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZA+VEN	Different induction chemotherapy regimens	Two courses of azacitidine combined with venetoclax as induction regimen
DA/IA 3+7	Different induction chemotherapy regimens	Daunorubicin or Idarubicin ×3 days combined with cytarabine × 7 days as induction regimen
DA/IA 2+5+VEN	Different induction chemotherapy regimens	Daunorubicin or Idarubicin ×2 days, cytarabine × 5 days combined with venetoclax as induction regimen

Primary Outcome Measures

Name	Time	Method
Event-free survival (EFS)	Up to approximately 2 years	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, China