Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia
NCT ID: NCT04485052
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1/PHASE2
222 participants
INTERVENTIONAL
2020-09-25
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IBI188+azacitidine
1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH)
IBI188
anti-CD47 Monoclonal antibody
Azacitidine
Demethylation drugs
IBI188+decitabine
R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)
IBI188
anti-CD47 Monoclonal antibody
Decitabine
Demethylation drugs
Interventions
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IBI188
anti-CD47 Monoclonal antibody
Azacitidine
Demethylation drugs
Decitabine
Demethylation drugs
Eligibility Criteria
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Inclusion Criteria
2. Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( ≥60 ys).
3. Age ≥18 years old, gender not limited.
4. ECOG score of 0-2.
5. Adequate organ function.
Exclusion Criteria
2. 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.
3. Major surgery and vaccine treatment within 4 weeks.
4. Uncontrolled concurrent diseases.
5. Pregnant or breastfeeding female subjects.
18 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Other Identifiers
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CIBI188B201
Identifier Type: -
Identifier Source: org_study_id
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