Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML Patients
- Registration Number
- NCT04839341
- Lead Sponsor
- Apollomics Inc.
- Brief Summary
This study will evaluate the safety and tolerability of uproleselan(GMI-1271), a specific E-selectin antagonist, and characterize the pharmacokinetic (PK) profile of uproleselan, in combination with chemotherapy to treat Chinese relapsed/refractory AML patients.
- Detailed Description
This study is a multicenter open-labelled study conducted in subjects with relapsed or refractory AML in China. The study includes the following phases: screening phase, induction phase, consolidation phase baseline, consolidation phase and follow-up period.
Screening phase:
This study will enroll 12 subjects, who are 18 to 60 years (inclusive) at the time of signing the Informed Consent Form (ICF), and with the diagnosis as relapsed or refractory AML. Screening is conducted 21 days to 2 days before administration, and signed ICF by the subject must be obtained before screening.
Baseline period:
The baseline period is 1 day before study drug administration.
Induction treatment:
During the induction phase, subjects will receive 8 consecutive days of uproleselan treatment and 5 consecutive days of MEC (mitoxantrone, etoposide, and cytarabine combined regimen) chemotherapy.
Consolidation baseline:
The baseline of the consolidation phase is 1 day before the treatment administration of the consolidation phase.
Consolidation treatment:
Subjects who met the criteria for consolidation treatment started the consolidation period at the 29th day of the previous treatment cycle at the earliest and the 65th day at the latest.
Follow-up period:
Each subject should complete the following follow-up stage: (1) Response evaluation to determine remission to the induction treatment (induction period); (2) EOT assessment after completing the last consolidation treatment cycle; (3) Death. Survival and long-term follow-up, including initiation of new anti-leukemia treatment (within 6 months after the last uproleselan/placebo administration), recurrence, HSCT and survival events, monthly (±14 days) for 2 years after the end of treatment, and afterwards quarterly (±14 days). The longest survival follow-up time is 3 years (calculated from the start of treatment).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Phase I, open-labeled multicenter study Uproleselan Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC)
- Primary Outcome Measures
Name Time Method Peak plasma concentration (Tmax) 14 days To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Peak plasma concentration (Cmax) 14 days To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Area under the plasma concentration-time curve from time zero to 12 hours (AUC0-12) 14 days To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
The area under the plasma concentration-time curve (AUC0-t) from time zero to the last measurable time point 14 days To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
The Incidence of Adverse Events Up to 10 months Number of participants with an AE.
The tolerance of participants with relapsed/refractory AML. Up to 10 months Number of participants could tolerate the Uproleselan combined with chemotherapy.
- Secondary Outcome Measures
Name Time Method OS Up to 3 years Defined as the period from when the subject receives the first dose of the study drug to death from any cause;
Remission rate (rate of CR, CR/CRi and CR/CRh) Up to 60 days Defined as the rate of subjects who reach CR, CR/CRi and CR/CRh;
CTCAE grade 3 and 4 oral mucositis Up to 254 days The incidence of CTCAE grade 3 and 4 oral mucositis during the treatment duration.
Trial Locations
- Locations (2)
The First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
🇨🇳Tianjin, Tianjin, China