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NCT Number: NCT06066242

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Different induction chemotherapy regimens

Other

azacitidine combined with venetoclax or chemotherapy with or without venetoclax

Primary outcomes

  1. Event-free survival (EFS)

    Time frame: 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 outcomes

  1. 30-day postinduction mortality

    Time frame: Up to approximately 30 days

    It is defined as death from any cause within 30 days after the start of induction.

  2. Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate

    Time frame: Up to approximately eight weeks

    Proportion of patients with CR, CRh or CRi

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

    Time frame: Up to approximately eight weeks

    Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative

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

    Time frame: Up to approximately 1 years

    The proportion of patients with negative MRD results at any time during treatment

  5. Relapse-free Survival (RFS)

    Time frame: 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.

  6. Overall survival (OS)

    Time frame: Up to approximately 2 years

    It is defined as the time from the start of randomization to the death from any cause.

  7. 60-day postinduction mortality

    Time frame: Up to approximately 60 days

    It is defined as death from any cause within 60 days after the start of induction.

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 4, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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