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 (Jun 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
Treatments studied
Chemotherapy
Other
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.
Frequently asked questions
Is NCT06647862 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with BCR alterations eligible?
No. BCR fusion is an exclusion criterion.
Are patients with ABL alterations eligible?
No. ABL fusion is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages