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

NCT ID: NCT06066242

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-10-10

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AZA+VEN

Two courses of azacitidine combined with venetoclax as induction regimen

Group Type: EXPERIMENTAL

Different induction chemotherapy regimens

Intervention Type: OTHER

azacitidine combined with venetoclax or chemotherapy with or without venetoclax

DA/IA 3+7

Daunorubicin or Idarubicin ×3 days combined with cytarabine × 7 days as induction regimen

Group Type: EXPERIMENTAL

Different induction chemotherapy regimens

Intervention Type: OTHER

azacitidine combined with venetoclax or chemotherapy with or without venetoclax

DA/IA 2+5+VEN

Daunorubicin or Idarubicin ×2 days, cytarabine × 5 days combined with venetoclax as induction regimen

Group Type: EXPERIMENTAL

Different induction chemotherapy regimens

Intervention Type: OTHER

azacitidine combined with venetoclax or chemotherapy with or without venetoclax

Interventions

Different induction chemotherapy regimens

azacitidine combined with venetoclax or chemotherapy with or without venetoclax

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Wei, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, China

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Wei, MD

Role: CONTACT

weihui@ihcams.ac.cn

86-022-23909020

Facility Contacts

Hui Wei, MD

Role: primary

Other Identifiers

IIT2023059

Identifier Type: -

Identifier Source: org_study_id