Status:
TERMINATED
Phase I Study of HMPL-523+Azacitidine in Elderly Patients With Acute Myeloid Leukemia
Lead Sponsor:
Hutchison Medipharma Limited
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, open-label, non-randomized, multicenter study to evaluate the safety, pharmacokinetics and preliminary efficacy of HMPL-523 in combination with Azacitidine in previously untreated e...
Detailed Description
There are two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2). Dose-escalation stage (stage 1): The conventional 3+3 design (3 patients per dose cohort, ...
Eligibility Criteria
Inclusion
- Subject must have confirmation of AML by WHO criteria, except for APL (M3)
- Subject must be ≥ 65 years of old and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors
- Subject must have received no prior treatment for AML with the exception of hydroxyurea
- ECOG performance status of 0-1. For dose-expansion stage, ECOG PS of 2 will also be eligible
Exclusion
- Subject has received treatment of hypomethylating agent and/or chemo therapeutic agent for MDS or MPN
- Subject has known active CNS involvement or extramedullary sarcoma from AML
- Subject has favorable risk cytogenetics as categorized by the NCCN Guidelines Version 1, 2018 for Acute Myeloid Leukemia, such as inv(16) or t(16;16) or t(8;21) or t(15;17)
- Subject has a white blood cell count \> 25 × 109/L (Hydroxyurea is permitted to meet this criterion)
- Subject with serum amylase or lipase \> the ULN
- Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load.
- Subject who don't have enough liver or renal function
- Subject with New York Heart Association (NYHA) Class III or greater congestive heart failure
- Subject received herbal therapy ≤ 1 week prior to initiation of study treatment
- Subject received prior treatment with any SYK inhibitors (Fostamatinib) or FLT3 inhibitor (Quizartinib) or multi-target inhibitor with SYK or FLT3 inhibition activity (Midostaurin)
Key Trial Info
Start Date :
October 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03483948
Start Date
October 9 2018
End Date
September 9 2019
Last Update
November 20 2019
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020