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RecruitingLast updated: 7 February 2024

This Phase I/II trial is evaluating how safe, tolerable and effective a targeted therapy (BGB-11417) is when combined with azacitidine (an anti-cancer drug) in people with acute myeloid leukaemia and myelodysplastic syndromeA Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies

Clinical summary

Summary

This is a non-randomised, open-label trial with two cohorts: one for patients with acute myeloid leukaemia (AML) and one for patients with myelodysplastic syndromes (MDS). Both cohorts will receive treatments in two phases. Phase one is testing two different treatment cycles of BGB-11417 (orally) and azacitidine (via intravenous [IV] or subcutaneous [SC] injection). In Phase 2, the cycle determined in the initial phase will be applied, or a subset of patients may receive a modified treatment.

Conditions

This trial is treating patients with acute myeloid leukaemia and myelodysplastic syndromes.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies

Eligibility

Inclusion

  1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:

    • AML, nonacute promyelocytic leukemia
    • MDS
    • MDS/MPN
  2. Eastern Cooperative Oncology Group performance status of 0 to 2.

  3. Adequate organ function defined as:

    • Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort)
    • Adequate liver function
  4. Life expectancy of > 12 weeks.
  5. Ability to comply with the requirements of the study.

Exclusion

  1. A diagnosis of acute promyelocytic leukemia.
  2. Prior malignancy within the past 2 years, except for curatively treated localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer.
  3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
  4. Prior therapy with a B-cell lymphoma-2 inhibitor or azacitidine except for participants who meet HMA-failure criteria
  5. Known central nervous system involvement by leukemia.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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