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

The experimental group receives two cycles of inducation chemotherapy consisting of venetoclax combined with standard DA 3+7 regimen. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks. The consolidation chemotherapy regimen consists of three cycles of intermediate （for age\>55 years）or high（for age≤ 55 years） dose cytarabine combined with venetoclax.

The control group receives two cycles of inducation chemotherapy consisting of standard DA 3+7 regimen without venetoclax. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks. The consolidation chemotherapy regimen consists of three cycles of intermediate （for age\>55 years）or high（for age≤ 55 years） dose cytarabine without venetoclax.

with or without venetoclax

Jianxiang Wang, Dr

300 patients will be randomly distributed into the control group (n=150) and the experimental group(n=150). Patients will receive two cycles of induction chemotherapy. The control group receives standard 3+7 induction regimen containing cytarabine (100mg/m2 d1-7) and daunorubicin (60mg/m2 d1-3). The experimental group receives venetoclax combined with intensive chemotherapy (3+7 induction regimen same as the control group). For each group, patients who fail to achieve CR/CRi after two courses of induction therapy may receive alternative therapy decided by their physicians. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks: subjects in favorable risk group should continue with chemotherapy; subjects in poor risk group should go through transplantation; for subjects in intermediate risk group, those with suitable donors can receive transplantation while others can continue with consolidation therapy. Subjects receive 3 courses of intermediate-dose cytarabine (1.5g/m2 q12h d1, 3, 5) for age\>55 years or high dose cytarabine (3g/m2 q12h d1, 3, 5) for age≤ 55 years as consolidation therapy with venetoclax in experimental group and without venetoclax in control group. After consolidation, patients will be observed.

Intensive Therapy Combined With Venetoclax for Adult Acute Myeloid Leukemia

A Phase 2/3 Prospective, Randomized, Controlled, Parallel Group Study of Intensive Therapy Combined With Venetoclax for Newly Diagnosed Adult Acute Myeloid Leukemia

The time from randomization to treatment failure, death from any cause or relapse after achieving CR or CRi, whichever occurs first.

The time from randomization to death resulting from any cause

The proportion of patients achieving CR after two cycles of induction chemotherapy.

The proportion of AML patients achieving CR/CRi with negativity for a genetic marker by real-time quantitative polymerase chain reaction and/or with negativity by multi-color flow cytometry.

From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day.

Calculated from tdate of first CR to the date of relapse, considering nonrelapse mortality (NRM) as a competing event

Adverse clinical events in the course of drug treatment according to CTCAE v5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intensive Therapy Combined With Venetoclax for Adult Acute Myeloid Leukemia	NCT05356169	Acute Myeloid L...	with or without...	18 Years - 65 Years	Institute of Hematology & Blood Diseases Hospital, China
Intensive Therapy Combined With Venetoclax for Adult Acute Myeloid Leukemia	NCT05356169	Acute Myeloid L...	with or without...	18 Years - 65 Years	Institute of Hematology & Blood Diseases Hospital, China

Spots Global Cancer Trial Database for with or without venetoclax