OncoMatch/Clinical Trials/NCT06647862
IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
Is NCT06647862 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including IMM01 and Azacitidine for chronic myelomonocytic leukemia.
Treatment: IMM01 · Azacitidine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: BCR fusion
Patients positive for BCR-ABL fusion genes ... need to be excluded
Excluded: ABL fusion
Patients positive for BCR-ABL fusion genes ... need to be excluded
Excluded: PDGFRA rearrangement
Patients positive for ... PDGFRA, PDGFRB, and FGFR1 rearrangements need to be excluded
Excluded: PDGFRB rearrangement
Patients positive for ... PDGFRA, PDGFRB, and FGFR1 rearrangements need to be excluded
Excluded: FGFR1 rearrangement
Patients positive for ... PDGFRA, PDGFRB, and FGFR1 rearrangements need to be excluded
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy for CMML (azacitidine, decitabine)
Exception: chemotherapy <1 cycle and washout >28 days is acceptable; supportive care (blood transfusions, growth factors) is permitted
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
Cannot have received: allogeneic stem cell transplant
allogeneic stem cell transplant for CMML
Cannot have received: anti-CD47 monoclonal antibody/SIRPα fusion protein
Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein
Cannot have received: autologous haematopoietic stem cell transplant
Patients who have undergone autologous haematopoietic stem cell transplant
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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