NCT06647862 IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
| NCT ID | NCT06647862 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. |
| Condition | Chronic Myelomonocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2024-11-11 |
| Primary Completion | 2026-04-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 170 participants in total. It began in 2024-11-11 with a primary completion date of 2026-04-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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;
Contact & Investigator
zhijian xiao, PHD
PRINCIPAL INVESTIGATOR
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Frequently Asked Questions
Who can join the NCT06647862 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Myelomonocytic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06647862 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 170 participants.
Is NCT06647862 currently recruiting?
Yes, NCT06647862 is actively recruiting participants. Contact the research team at yujuan.ma@immuneonco.com for enrollment information.
Where is the NCT06647862 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Chongqing, China, Lanzhou, China and 11 additional locations.
Who is sponsoring the NCT06647862 clinical trial?
NCT06647862 is sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Inc.. The principal investigator is zhijian xiao, PHD at Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. The trial plans to enroll 170 participants.
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