This study aims to investigate whether immediate HSCT for patients with high-risk AML and intermediate-risk AML who have not achieved complete remission (CR) after their first induction therapy is non-inferior to re-treatment with chemotherapy.
1. Disease control group: patients proceeded to allogeneic HSCT as soon as possible. Patients were allowed to receive low-dose chemotherapy that is not intended for the purpose of achieving a second remission. 2. Retreatment group: Receive a second course of anti-leukemic treatment prior to allogeneic HSCT. The anti-leukemic treatment regimen will be determined based on the genetic mutation status. Patients without targetable mutations will receive a combination of BCL-2 inhibitors and demethylating agents as salvage chemotherapy. Patients with targetable mutations will receive appropriate targeted therapy (e.g., FLT3 inhibitors, IDH inhibitors). For patients who have already received targeted therapy during induction treatment, the researchers may choose the treatment regimen based on the individual patient's condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
358
patients proceeded to allogeneic HSCT as soon as possible. Patients were allowed to receive low-dose chemotherapy that is not intended for the purpose of achieving a second remission.
Receive a second course of anti-leukemic treatment prior to allogeneic HSCT. The anti-leukemic treatment regimen will be determined based on the genetic mutation status. Patients without targetable mutations will receive a combination of BCL-2 inhibitors and demethylating agents as salvage chemotherapy. Patients with targetable mutations will receive appropriate targeted therapy (e.g., FLT3 inhibitors, IDH inhibitors).
Hebei Medical University Second Hospital
Shijiazhuang, Hebeisheng, China
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, China
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan, Shandong, China
People's Liberation Army The General Hospital of Western Theater Command
Chengdu, Sichuan, China
treatment success
The primary endpoint, treatment success defined as complete remission on day 56 after allogeneic HCT, was defined as dichotomous success rate.
Time frame: day 56 after allogeneic HCT
Cumulative Incidences of Allogeneic HSCT
1. Starting point: Randomization 2. Event: allogeneic HCT 3. Competing events: death, withdrawal
Time frame: HSCT rates at 4,8,16, and 24 weeks
Incidence of Complete Remission from Randomisation
1. Starting point: randomization 2. Event: Date of first documented CR or CRi or CRchim 3. Competing Event: Death before CR/CRi/CRchim 4. Administrative Censoring: not achieve a CR or CRi by six months b) Starting point: day 56 c) Events: Relapse (both, hematologic or molecular) and death
Time frame: Date of first documented CR or CRi or CRchim Death before CR/CRi/CRchim not achieve a CR or CRi by six months
Overall survival after HCT
1. Starting point: HCT 2. Event: Death
Time frame: Death
Event-free survival after HCT
1. Starting point: HCT 2. Events: death before relapse, relapse (both, hematological or molecular), and failure to achieve a CR at final remission assessment
Time frame: death before relapse, relapse (both, hematological or molecular), and failure to achieve a CR at final remission assessment
Leukemia-free survival from day 56 after alloHCT for patients who met the primary endpoint
efined only for per-protocol treated patients who met the primary endpoint b) Starting point: day 56 c) Events: Relapse (both, hematologic or molecular) and death
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Time frame: day 56
Rate of MRD Negative from Day 56 after HSCT
1. defined only for per-protocol treated patients who met the primary endpoint 2. Starting point: day 56 3. Events: MRD Negative (including MPFC, qPCR and NGS) and death
Time frame: day 56
7. Overall Survival from Randomization: Measured from the start of randomization, with the primary event being death.
1. Starting point: Randomization 2. Event: Death
Time frame: Death