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

Recruiting Phase 3 Interventional Study
Chronic Myelomonocytic Leukemia
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Other
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About This Trial

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.

Trial Locations
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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 …
Contacts

Yujuan Ma

86-15021694761

yujuan.ma@immuneonco.com

CONTACT