To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
458
in arm 1
in arms 2-5
in arm 2
in arms 4 and 7
in arms 3 and 7
in arms 3 and 7
in arms 1，2 , 5 and 8
in arms 7 and 8
Blood Hospital
Tianjin, China
RECRUITINGComplex response (CRc) rate (including CR and CRi)
Proportion of patients with combined responses (complete and partial responses)
Time frame: up to 4 years
mortality associated with salvage treatment (30 days, 60 days)
Mortality of patients treated within 30 and 60 days
Time frame: Treatment within 30 days and 60 days
MRD-negative complete response rate
Proportion of patients with complete response and MRD negative
Time frame: the whole period of the trial, up to 730 days
Overall survival
Used to evaluate all patients entering clinical trials
Time frame: the whole period of the trial, up to 730 days
Event-free survival
It is only used to evaluate patients who have achieved CR
Time frame: the whole period of the trial, up to 730 days
Relapse-free survival
It is only used to evaluate patients who have achieved CR
Time frame: the whole period of the trial, up to 730 days.
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