IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
ID: NCT06647862
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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.
IV infusion
subcutaneous injection
IV infusion
Treatment Arms Description
One treatment cycle consists of 4 weeks (28 days). IMM01(timdarpacept) will be administered once weekly, and azacitidine will be administered from Day 1 to Day 7 of each cycle.
One treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and azacitidine will be administered on days 1-7 of each cycle.
- Age ≥ 18 years old, regardless of gender;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Life expectancy ≥ 12 weeks;
- Patients with CMML diagnosed according to WHO 2016 criteria, including CMML-1 and CMML-2;
- White blood cell count ≤ 13×10⁹/L before the first treatment with the study drug (hydroxyurea and leukapheresis are allowed).
- Patients must be treatment-naïve to any systemic agents for CMML (e.g., azacitidine, decitabine,chemotherapy\<1 cycle, and the washout period should be more than 28 days, which is acceptable.), allogeneic stem cell transplant for CMML. Note: During screening and study participation, subjects may continue oral corticosteroids for diseases other than CMML (e.g. asthma) at a stable daily dose equivalent to ≤ 10 mg prednisone. In addition, supportive care in the form of blood transfusions or growth factors is not considered prior therapy in this case and is permitted prior to and as needed during the study.
- Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein;
- History of allogeneic stem cell transplant and other organ transplants; Patients who have undergone autologous haematopoietic stem cell transplant;
- Prior diagnosis of: therapy-related Myelodysplastic syndrome / Myeloproliferative neoplasm(MDS/MPN); MDS evolved from a pre-existing Myelodysplastic syndrome / Myeloproliferative neoplasm (MDS/MPN) ;other MDS/MPN including atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN. Patients positive for BCR-ABL fusion genes, PDGFRA, PDGFRB, and FGFR1 rearrangements need to be excluded;
- Current or history of central nervous system (CNS) leukemia, extramedullary leukemia(excluding: Enlarged spleen, enlarged liver, enlarged lymph nodes), or myeloid sarcoma;
- Diagnosis of other malignant neoplasms within 3 years prior to the first dose. Exceptions: a. Radically treated cervical carcinoma in situ or non-melanoma skin cancer,Surgery-cured prostate cancer and papillary thyroid cancer; b. a second primary cancer that has been curatively treated and has no recurrence within three years;
Primary Outcome Measures
- Complete remission( CR) rate — Time Frame: approximately 24 months
CR rate: CR rate determined by Independent Review Committee (IRC) based on IWG2006 MDS efficacy evaluation criteria;
- Overall survival (OS) — Time Frame: approximately 24 months
Overall survival (OS): Time from randomization to death from any cause;
View Secondary Outcome Measures (8)
- Event-free survival(EFS) — Time Frame: approximately 24 months
Time from randomization to transformation to AML or death from any cause, whichever occurs first
- Progression-free survival(PFS) — Time Frame: approximately 24 months
Time from randomization to transformation to AML or death from any cause, whichever occurs first
- Time to response (TTR) — Time Frame: approximately 24 months
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
- overall response rate(ORR) — Time Frame: approximately 24 months
is defined as the proportion of the analysis population achieving CR, PR, mCR±HI, or HI
- Duration of response(DOR) — Time Frame: approximately 24 months
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
- Red blood cell transfusion independence (RTI) — Time Frame: approximately 24 months
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.
- Complete remission(CR) rate — Time Frame: approximately 24 months
CR rate determined by IRC based on IWG2006 MDS efficacy evaluation criteria assessed by the investigator;
- Time to transformation to acute myeloid leukemia — Time Frame: approximately 24 months
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.
This trial is recruiting at 43 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 43 Facilities & Contact Sites
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View Official Medical/Scientific Title
A Randomized, Controlled, Double-Blind, Multicenter, Phase Ⅲ Study to Evaluate the Efficacy and Safety of IMM01 (Timdarpacept) in Combination With Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)