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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 43
- 主要终点
- Complete remission( CR) rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, regardless of gender;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •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.
排除标准
- •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;
研究组 & 干预措施
IMM01 in combination with azacitidine
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.
干预措施: IMM01 (Drug)
IMM01 in combination with azacitidine
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.
干预措施: Azacitidine (Drug)
placebo in combination with azacitidine
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.
干预措施: Azacitidine (Drug)
placebo in combination with azacitidine
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Complete remission( CR) rate
时间窗: approximately 24 months
CR rate: CR rate determined by Independent Review Committee (IRC) based on IWG2006 MDS efficacy evaluation criteria;
Overall survival (OS)
时间窗: approximately 24 months
Overall survival (OS): Time from randomization to death from any cause;
次要结局
- Event-free survival(EFS)(approximately 24 months)
- Progression-free survival(PFS)(approximately 24 months)
- Time to response (TTR)(approximately 24 months)
- overall response rate(ORR)(approximately 24 months)
- Duration of response(DOR)(approximately 24 months)
- Red blood cell transfusion independence (RTI)(approximately 24 months)
- Complete remission(CR) rate(approximately 24 months)
- Time to transformation to acute myeloid leukemia(approximately 24 months)