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Recruiting NCT06647862

IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

Phase III Interventional Chronic Myelomonocytic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IMM01, Azacitidine, Placebo.
Who it may be relevant to
Registry conditions: Chronic Myelomonocytic Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Controlled, Double-Blind, Multicenter, Phase Ⅲ Study to Evaluate the Efficacy and Safety of IMM01 (Timdarpacept) in Combination With Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

Overview

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

  • Drug IMM01
    IV infusion
  • Drug Azacitidine
    subcutaneous injection
  • Drug Placebo
    IV infusion

Primary outcome measures

  • Complete remission( CR) rate [Time frame: approximately 24 months]
  • Overall survival (OS) [Time frame: approximately 24 months]
Secondary outcome measures (8)
  • Event-free survival(EFS) [Time frame: approximately 24 months]
  • Progression-free survival(PFS) [Time frame: approximately 24 months]
  • Time to response (TTR) [Time frame: approximately 24 months]
  • overall response rate(ORR) [Time frame: approximately 24 months]
  • Duration of response(DOR) [Time frame: approximately 24 months]
  • Red blood cell transfusion independence (RTI) [Time frame: approximately 24 months]
  • Complete remission(CR) rate [Time frame: approximately 24 months]
  • Time to transformation to acute myeloid leukemia [Time frame: approximately 24 months]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 43 centers
  • Anhui Provincial Hospital — Hefei
  • China-Japan Friendship Hospita — Beijing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • First Hospital of Lanzhou University — Lanzhou
  • The First Affiliated Hospital of Guangxi Medical University — Nanning
  • Nanfang Hospital, Southern Medical University — Guangzhou
  • Shenzhen Second People's Hospital — Shenzhen
  • Zhujiang Hospital of Southern Medical University — Zhujiang
  • … and 35 more centers

Identifiers

NCT: NCT06647862 · IMM01-010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗