Relapsed/Refractory AML Clinical Trial
Official title:
A Phase I, Open-labeled Multicenter Study to Determine Pharmacokinetics, Safety, Tolerability and Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With Relapsed/Refractory Acute Myeloid Leukemia
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | February 28, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Key Criteria: 1. =18 years and =60 years in age 2. AML (including secondary AML) diagnosed as per WHO standards (2008). 3. For refractory AML, only cytarabine/daunorubicin(or Idarubicin) as can be applied repeatedly(maximal twice) as induction, no other chemotherapy are allowed to be applied Venatoclax /hypomethylation drug [HMA] can be used before and after chemotherapy. 1. For relapse AML, it must be the first or second relapse, and remain untreated. 2. Certain regimens (Venatoclax/HMA, Venetoclax/LDAC, HMA single agent) and FLT3 inhibitors, tyrosine kinase inhibitors, IDH1/IDH2 inhibitors or similar targeted inhibitors used alone are not considered cytotoxic chemotherapy are allowed. 4. ECOG performance status score is 0 to 2. 5. Stable hemodynamics and good organ function and good organ function. Exclusion key Criteria: 1. Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML. 2. Active signs or symptoms of CNS involvement by malignancy. 3. Stem cell transplantation =4 months prior to dosing. 4. Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing. 5. Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing. 6. Inadequate organ function. 7. Abnormal liver function. 8. Known active infection with hepatitis A, B, or C, or human immunodeficiency virus. 9. Moderate kidney dysfunction (glomerular filtration rate <45 mL/min). 10. Uncontrolled acute life-threatening bacterial, viral, or fungal infection. 11. Clinically significant cardiovascular disease. 12. Major surgery within 4 weeks of dosing. |
Country | Name | City | State |
---|---|---|---|
China | 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 |
Lead Sponsor | Collaborator |
---|---|
Apollomics Inc. | Zhejiang CrownMab Biotech Co. Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak plasma concentration (Tmax) | To assess the pharmacokinetic profile in patients with relapsed/refractory AML. | 14 days | |
Primary | Peak plasma concentration (Cmax) | To assess the pharmacokinetic profile in patients with relapsed/refractory AML. | 14 days | |
Primary | Area under the plasma concentration-time curve from time zero to 12 hours (AUC0-12) | To assess the pharmacokinetic profile in patients with relapsed/refractory AML. | 14 days | |
Primary | The area under the plasma concentration-time curve (AUC0-t) from time zero to the last measurable time point | To assess the pharmacokinetic profile in patients with relapsed/refractory AML. | 14 days | |
Primary | The Incidence of Adverse Events | Number of participants with an AE. | Up to 10 months | |
Primary | The tolerance of participants with relapsed/refractory AML. | Number of participants could tolerate the Uproleselan combined with chemotherapy. | Up to 10 months | |
Secondary | OS | Defined as the period from when the subject receives the first dose of the study drug to death from any cause; | Up to 3 years | |
Secondary | Remission rate (rate of CR, CR/CRi and CR/CRh) | Defined as the rate of subjects who reach CR, CR/CRi and CR/CRh; | Up to 60 days | |
Secondary | CTCAE grade 3 and 4 oral mucositis | The incidence of CTCAE grade 3 and 4 oral mucositis during the treatment duration. | Up to 254 days |
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