This study is a randomized, controlled, double-blind, multicenter, phase Ⅲ clinical study to evaluate the efficacy of IMM01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (CMML1-2).Primary endpoint are Complete remission rate and Overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
Complete remission( CR) rate
CR rate: CR rate determined by Independent Review Committee (IRC) based on IWG2006 MDS efficacy evaluation criteria;
Time frame: approximately 24 months
Overall survival (OS)
Overall survival (OS): Time from randomization to death from any cause;
Time frame: approximately 24 months
Event-free survival(EFS)
Time from randomization to transformation to AML or death from any cause, whichever occurs first
Time frame: approximately 24 months
Progression-free survival(PFS)
Time from randomization to transformation to AML or death from any cause, whichever occurs first
Time frame: approximately 24 months
Time to response (TTR)
time from first dose to first occurrence of CR, partial remission (PR), marrow complete remission (mCR) ± hematologic improvement (HI), HI, assessed by IRC and investigators, respectively
Time frame: approximately 24 months
overall response rate(ORR)
is defined as the proportion of the analysis population achieving CR, PR, mCR±HI, or HI
Time frame: approximately 24 months
Duration of response(DOR)
is defined as the time from the first occurrence of CR, PR, mCR±HI, or HI to disease progression or death from any cause, whichever occurs first
Time frame: approximately 24 months
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Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGChina-Japan Friendship Hospita
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFirst Hospital of Lanzhou University
Lanzhou, Gansu, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Gaungxi, China
RECRUITINGNanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGShenzhen Second People's Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGZhujiang Hospital of Southern Medical University
Zhujiang, Guangdong, China
NOT_YET_RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangzhou, China
RECRUITINGAffiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITING...and 33 more locations
Red blood cell transfusion independence (RTI)
the proportion of patients who did not receive red blood cell (or whole blood) transfusion for 8 consecutive weeks during the study treatment period among patients who required transfusion at baseline.
Time frame: approximately 24 months
Complete remission(CR) rate
CR rate determined by IRC based on IWG2006 MDS efficacy evaluation criteria assessed by the investigator;
Time frame: approximately 24 months
Time to transformation to acute myeloid leukemia
Time from initiation of study treatment to transformation to AML; defined as ≥ 20% blasts in the bone marrow or peripheral blood by manual differential count, according to the 2016 WHO classification criteria.
Time frame: approximately 24 months