Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia

Innovent Biologics

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Azacitidine; Drug: IBI188; Drug: Decitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04485052

CIBI188B201

Details and patient eligibility

About

The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia

Enrollment: 222 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML).
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

1. Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase).
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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

IBI188+azacitidine

Experimental group

Description:

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)

Treatment:

Drug: IBI188

Drug: Azacitidine

IBI188+decitabine

Experimental group

Description:

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)

Treatment:

Drug: IBI188

Drug: Decitabine