Study to Evaluate the Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With R/R AML
Sponsored by Apollomics Inc.
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
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.
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.