Status:
SUSPENDED
Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia
Eligibility Criteria
Inclusion
- AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML).
- Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( ≥60 ys).
- Age ≥18 years old, gender not limited.
- ECOG score of 0-2.
- Adequate organ function.
Exclusion
- Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase).
- A history of myeloproliferative diseases (including myelofibrosis, primary thrombocytosis, and true red) Cytosis, chronic myelocytic leukemia) or acute myeloid white blood with BCR-ABL1 translocation Patients.
- Major surgery and vaccine treatment within 4 weeks.
- Uncontrolled concurrent diseases.
- Pregnant or breastfeeding female subjects.
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT04485052
Start Date
September 25 2020
End Date
December 31 2024
Last Update
October 23 2023
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006