Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Venetoclax

Azacitidine

Daunorubicin

Idarubicin

Two courses of azacitidine combined with venetoclax as induction regimen

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

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

azacitidine combined with venetoclax or chemotherapy with or without venetoclax

Different induction chemotherapy regimens

Hui Wei, MD

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.

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

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

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).

Proportion of patients with CR, CRh or CRi

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

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

It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up.

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy	NCT06066242	Acute Myeloid L...	Different induc...	60 Years - 75 Years	Institute of Hematology & Blood Diseases Hospital, China
Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy	NCT06066242	Acute Myeloid L...	Different induc...	60 Years - 75 Years	Institute of Hematology & Blood Diseases Hospital, China

Spots Global Cancer Trial Database for different induction chemotherapy regimens