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

NCT06066242 | Active Not Recruiting

• 1 other identifier: IIT2023059
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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 screen the safety and efficacy of two induction regimens (Ven+AZA and DA/IA 2+5+VEN) in order to select one as the experimental arm in the sebsequent 3 phase RCT study. A total of 90 patients will be enrolled in this study and segregated into three 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

Keywords

elderly; newly diagnosed; fit; induction regimen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 30-day postinduction mortality

  Up to approximately 30 days

• 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

• Minimal residual disease (MRD)-negative remission rates after induction

  Up to approximately eight weeks

• Cumulative incidence of minimal residual disease (MRD)-negative remission rates

  Up to approximately 1 years

• Relapse-free Survival (RFS)

  Up to approximately 2 years

Study Arms (3)

AZA+VEN

EXPERIMENTAL

Azacitidine combined with venetoclax as induction regimen

Other: Different induction chemotherapy regimens

DA/IA 3+7

ACTIVE COMPARATOR

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

Other: Different induction chemotherapy regimens

DA/IA 2+5+VEN

EXPERIMENTAL

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

Other: Different induction chemotherapy regimens

Interventions

Different induction chemotherapy regimens OTHER

azacitidine combined with venetoclax or chemotherapy with or without venetoclax

AZA+VEN; DA/IA 2+5+VEN; DA/IA 3+7

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the study and voluntarily sign informed consent.
• Age: 60\~75 years old, gender unlimited.
• 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.
• Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2.
• Fit for intensive chemotherapy.
• 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

You may not qualify if:

• Patients with acute promyelocytic leukemia
• Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene
• Patients with BCR::ABL fusion gene
• Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before.
• Patients with concurrent malignant tumors requiring treatment
• 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.
• Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hui Wei, MD

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): May 10, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

CN (1)