Evaluating IMM01 with Azacitidine for Newly Diagnosed Chronic Myelomonocytic Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, controlled, double-blind, multicenter phase 3 study designed to assess the efficacy of IMM01 (timdarpacept) in combination with azacitidine compared to a placebo with azacitidine in patients newly diagnosed with chronic myelomonocytic leukemia (CMML). The primary endpoints include the complete remission rate and overall survival of participants. Eligible patients must be treatment-naïve and meet specific criteria regarding their health status and blood cell counts. The study aims to provide insights into the potential benefits of this combination therapy for CMML patients.

Why it matters

Who can join: the full rules

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;

Where it's running

• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting
• China-Japan Friendship Hospita
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Gaungxi, China Recruiting
• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangzhou, China Recruiting
• Affiliated Hospital of Guizhou Medical University
  Guiyang, Guizhou, China Recruiting

Study contacts

• Principal investigator: zhijian xiao, PHD — Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
• Study coordinator: Yujuan Ma
• Email: yujuan.ma@immuneonco.com
• Phone: 86-15021694761

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.