Chronic Myelomonocytic Leukemia
Conditions
Brief summary
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.
Interventions
Sponsors
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission( CR) rate | approximately 24 months | CR rate: CR rate determined by Independent Review Committee (IRC) based on IWG2006 MDS efficacy evaluation criteria; |
| Overall survival (OS) | approximately 24 months | Overall survival (OS): Time from randomization to death from any cause; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to response (TTR) | 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) | approximately 24 months | is defined as the proportion of the analysis population achieving CR, PR, mCR±HI, or HI |
| Duration of response(DOR) | 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 |
| Event-free survival(EFS) | approximately 24 months | Time from randomization to transformation to AML or death from any cause, whichever occurs first |
| Complete remission(CR) rate | 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 | 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. |
| Red blood cell transfusion independence (RTI) | 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. |
| Progression-free survival(PFS) | approximately 24 months | Time from randomization to transformation to AML or death from any cause, whichever occurs first |
Countries
China
Contacts
Primary ContactYujuan Ma
Outcome results
None listed