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Closed (no longer recruiting)Last updated: 30 January 2024

ASLAN003-003: This Phase II trial is evaluating a new oral drug (ASLAN003) as a single treatment for Acute Myeloid Leukaemia (AML)A Phase IIA Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia

Clinical summary

Summary

This is a multicenter, single arm, non-randomised Phase IIA Study to evaluate ASLAN003 as a monotherapy in patients with AML. AML patients who are ineligible for standard treatment including, but not limited to the following conditions, will be enrolled in the study:

  • Newly diagnosed patients who are ineligible for standard therapy i.e., standard dose induction chemotherapy and reduced dose chemotherapy
  • Patients with relapse from prior remission
  • Patients with failed response to prior therapy including chemotherapy, hypomethylating agents, and bone marrow (BM) transplantation.

Up to a total of 18 patients will be enrolled into this study - 6 patients in each dose cohort (ASLAN003 100 mg once daily (QD), 200 mg QD, and 300 mg QD, respectively). Once 6 patients have been enrolled into the cohort of 100 mg QD, recruitment will be started in the cohort of 200 mg QD. The same rule applies on the cohort of 300 mg QD. A steering committee (SC) meeting will be set up and meet to review all safety data. Clinical information, including safety and PK data obtained from this Study, will be reviewed by a SC. All patients will continue to receive ASLAN003 until disease relapse, treatment failure, unacceptable toxicity, withdrawal of consent or death.

Conditions

This trial is treating patients with Acute Myeloid Leukaemia (AML).

Cancer

Blood Cancers Haematological

Age

People21+

Phase

II

Trial Acronym

ASLAN003-003

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Aslan Pharmaceuticals

Scientific Title

A Phase IIA Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia

Eligibility

Inclusion

  1. Patients who are of or older than 18 years old in the United States or are of or older than the legal age in the respective countries at the time when written informed consent is obtained
  2. Patients who are able to understand and willing to sign the informed consent form (ICF)
  3. Patients who are diagnosed with AML according to the 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia (refer to Appendix 1: WHO Classification of Acute Myeloid Leukemia)
  4. Patients who have a sufficient archival or fresh BM aspiration sample for the evaluation of relevant exploratory endpoint.

Note: Patients who do not have sufficient archival BM aspiration sample and refuse to repeat the procedure may be enrolled in the trial only after written confirmation by ASLAN 5. Part 1: Patients who are ineligible for standard treatment of AML including to the following conditions:

  • Patients who are ineligible for chemotherapy, and have exhausted any approved and available treatment options. More details on patients who are considered as ineligible or unfit for chemotherapy as per Ferrara et al, Leukemia, 2013 can be found in Appendix 4.
  • Patients who have relapsed from prior remission;
  • Patients who have failed to respond to prior therapy including chemotherapy, hypomethylating agents, and bone marrow transplantation.

    5. Part 2A: Patients who have relapsed or refractory AML to treatments including chemotherapy, hypomethylating agents, bone marrow transplantation, and other anti-leukemic agents

    • Relapsed patients who have bone marrow blasts ≥5%; or reappearance of blasts in the blood; or development of extramedullary disease after prior CR or CRi
    • Refractory patients who have no CR or CRi after 2 courses of intensive induction treatment 5. Part 2B: Older patients (more than or equal to 60 years) AML patients who have exhausted any approved and available treatment options.

      6. Patients who have an ECOG performance status of ≤ 2 7. Patients with adequate renal and hepatic function, as defined below:

  • Estimated Glomerular Filtration Rate (eGFR) or creatinine clearance (CrCl) (CrCl calculated by the Cockroft and Gault method) ≥ 40 ml/min/1.73 m2
  • Total bilirubin, AST, and ALT ≤ 1.5 × ULN

Exclusion

  1. Patients who are diagnosed with de novo myeloid sarcoma without BM involvement
  2. Patients who are diagnosed with acute promyelocytic leukemia/retinoic acid receptor alpha (PML-RARA)
  3. Patients who received any other standard or investigational treatment for their leukemia within the last 7 days before starting the first dose of study drug, with the exception of leukapheresis and hydroxyurea
  4. Patients with unresolved serious toxicity (≥ CTCAE 4.03 Grade 2) from prior administration of standard or investigational treatment for their leukemia
  5. Patients who have a positive test for human immunodeficiency virus (HIV), viral hepatitis C infection (patients with sustained viral response are not excluded), active viral hepatitis B infection (positive hepatitis B surface antigen [HBsAg]) with hepatitis B virus deoxyribonucleic acid (DNA) exceeding 2000 IU/ml
  6. Patients who have a known history of liver cirrhosis Child-Pugh score B or C
  7. Patients who have any history of other malignancy unless in remission for more than 1 year (skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent is not exclusionary)
  8. Female patients who are pregnant or breast-feeding
  9. Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment
  10. Patients with a history or presence of a clinically significant condition which in the opinion of the Investigator could jeopardize the safety of the patient or the validity of the study results
  11. Patients who have been previously treated with ASLAN003

Inclusion

  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
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Clinical trials have complex eligibility criteria.

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