Study to Evaluate the Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With R/R AML
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- ≥18 years and ≤75 years in age
- AML diagnosed with ≥20% myeloid marrow blasts or peripheral blood blasts per WHO criteria(2008) at the time of initial diagnosis
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.
- For relapse AML, it must be the first or second relapse, and remain untreated.
- 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.
- No more than one prior stem cell transplant
- Has not received the chemotherapy regimen to be used for induction on this trial
- Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial
EXCLUSION CRITERIA
Exclusion Criteria:
- Patients with acute promyelocytic leukemia
- Acute leukemia of ambiguous lineage (biphenotypic leukemia)
- Chronic myeloid leukemia with myeloid blast crisis
- Active signs or symptoms of CNS involvement by malignancy (No lumbar puncture required)
- Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
- Stem cell transplantation ≤4 months prior to dosing.
- Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing
- Inadequate organ function.
- Abnormal liver function.
- Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.
- Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).
- Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
- Clinically significant cardiovascular disease.
- Major surgery within 4 weeks of dosing.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Relapsed/Refractory AML
Age (in years)
18 - 75
Phase
Phase 3
Participants needed
140
Est. Completion Date
Feb 29, 2024
Treatment type
Interventional
Sponsor
Apollomics Inc.
ClinicalTrials.gov identifier
NCT05054543
Study number
APL-106-02
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