A Study to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-004403
    • Jacksonville, Florida: 16-004403
    NCT ID: NCT02632721
    Sponsor Protocol Number: 1315.2, 2015-002892-30

About this study

Phase I Dose Escalation: Primary objective is to determine the MTD and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine.

Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion criteria:

  • Phase I Dose Escalation:
    1. Male or female patients ≥ 18 years of age with relapsed or refractory AML
    2. Male or female patients ≥ 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy
  • Phase I Extension and Phase II:

Male or female patients ≥ 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy

  • Histologically or cytologically confirmed AML according to the WHO classification
  • Patients must be eligible for treatment with decitabine
  • Eastern co-operative oncology group (ECOG) performance score ≤2 at screening Further inclusion criteria apply

Exclusion criteria:

  • Acute promyelocytic leukemia (APL, French-American-British (FAB) subtype M3), according to WHO classification.
  • Patients who are candidates for allogeneic stem cell transplantation.
  • Active chronic graft versus host disease requiring immunosuppressive treatment.
  • Phase I extension and Phase II only: Prior treatment with a hypomethylating agent, such as prior treatment for MDS.
  • Prior treatment with Cluster of differentiation 33 (CD33) antibody Furthr exclusion criteria apply.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

James Foran, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

James Foran, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20316363

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