Study Stopped
Pause for changes in development strategies
Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia
A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia
1 other identifier
interventional
222
1 country
1
Brief Summary
The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2020
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2020
CompletedFirst Posted
Study publicly available on registry
July 24, 2020
CompletedStudy Start
First participant enrolled
September 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 23, 2023
October 1, 2023
3.8 years
July 21, 2020
October 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Composite complete rate
Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery
24 weeks
Secondary Outcomes (1)
Cytogenetic CR
24 weeks
Study Arms (2)
IBI188+azacitidine
EXPERIMENTAL1L 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+decitabine
EXPERIMENTALR/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2020
First Posted
July 24, 2020
Study Start
September 25, 2020
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
October 23, 2023
Record last verified: 2023-10