Relapsed/Refractory AML Clinical Trial
Official title:
A Phase 3 Randomized, Double-Blinded Bridging Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Chinese Patients With Relapsed/Refractory Acute Myeloid Leukemia
This bridging study will evaluate the efficacy of uproleselan, a specific E-selectin antagonist, in combination with chemotherapy to treat Chinese relapsed/refractory AML patients, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML
Status | Recruiting |
Enrollment | 140 |
Est. completion date | February 2024 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. =18 years and =75 years in age 2. AML diagnosed with =20% myeloid marrow blasts or peripheral blood blasts per WHO criteria(2008) at the time of initial diagnosis 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. No more than one prior stem cell transplant 5. Has not received the chemotherapy regimen to be used for induction on this trial 6. Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial Exclusion Criteria: 1. Patients with acute promyelocytic leukemia 2. Acute leukemia of ambiguous lineage (biphenotypic leukemia) 3. Chronic myeloid leukemia with myeloid blast crisis 4. Active signs or symptoms of CNS involvement by malignancy (No lumbar puncture required) 5. Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing. 6. Stem cell transplantation =4 months prior to dosing. 7. Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing 8. Inadequate organ function. 9. Abnormal liver function. 10. Known active infection with hepatitis A, B, or C, or human immunodeficiency virus. 11. Moderate kidney dysfunction (glomerular filtration rate <45 mL/min). 12. Uncontrolled acute life-threatening bacterial, viral, or fungal infection. 13. Clinically significant cardiovascular disease. 14. 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 | Overall survival | Time from the date of randomization into the study to the date of death. | 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 | Duration of remission | Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first. | Up to 3 years | |
Secondary | Event-free survival | Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first. | Up to 3 years | |
Secondary | Rate of severe oral mucositis | Incidence of severe oral mucositis experienced in patients after treatment. | Up to 254 days |
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