Skip to main content
OpenTrials
Completed

NCT Number: NCT02632721

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

Phase I Dose Escalation:

Primary objective is to determine the Maximum Tolerated Dose (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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Universitätsklinikum Augsburg, Augsburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1)

Phase I Dose Escalation:

  • Male or female patients >/= 18 years of age with relapsed or refractory AML
  • 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 3) Patients must be eligible for treatment with decitabine 4) 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 Myelodysplastic Syndrome (MDS).

  • Prior treatment with Cluster of differentiation 33 (CD33) antibody. Further exclusion criteria apply.

Treatment and study plan

decitabine

Drug

BI 836858

Drug

Primary outcomes

  1. Phase I: Number of Patients With Dose Limiting Toxicity (DLT(s)) During First Treatment Cycle

    Time frame: Up to 28 days (first treatment cycle).

    Number of patients with dose limiting toxicity (DLT(s)) for BI 836858 in combination with decitabine during first treatment cycle (Phase 1).

    DLT was defined as any non-disease-related non-haematological adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher. Expected non-haematological disease-related AEs were not to be regarded as a DLT.

    These included complications resulting from haematological AEs such as:

    • Bleeding and complications from bleeding due to thrombocytopenia as defined by the Investigator,
    • Infection and complications from infections due to neutropenia as defined by the Investigator,
    • Constitutional symptoms due to anaemia as defined by the Investigator

  2. Phase I: Maximum Tolerated Dose (MTD) of BI 836858 in Combination With Decitabine

    Time frame: From first drug administration until end of treatment, up to 941 days.

    The Maximum tolerated dose (MTD) of BI 836858 in combination with decitabine was estimated after the dose escalation part of the trial obtaining on the basis of dose limiting toxicities (DLT(s)) observed during the first treatment cycle. However, for those patients who receive more than one cycle of the combination treatment, all adverse events that constitute a DLT will be considered for re-estimation of the MTD based on the Bayesian logistic regression model (BLRM). The MTD is defined as the highest dose of BI 836858 (in combination with decitabine) with less than 25% risk of the true DLT rate being above 33% during the MTD evaluation period.

Secondary outcomes

  1. Phase 1: Number of Patients With Objective Response (CR + CRi)

    Time frame: From start of treatment until the earliest of progression, death or end of trial, up to 971 days.

    Number of patients with objective response (Complete remission (CR) + complete remission with incomplete remission (CRi)).

    CR was defined as bone marrow (BM) blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 109/L [1,000/μL]; platelet count > 100 x 109/L [100,000/μL]; independence of red blood cells transfusions (no transfusion for 1 week prior to the assessment). No minimum duration of response is required.

    CRi was defined as all CR criteria except for residual neutropenia (< 1.0 x 109/L [1,000/μL]) or thrombocytopenia (< 100 x 109/L [100,000/μL]).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open-label, Phase I/II Trial to Determine the Maximum Tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 836858 in Combination With Decitabine in Patients With Acute Myeloid Leukemia

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2015
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.