A study to find and investigate a safe dose of BI 836858 in combination with decitabine for patients with acute myeloid leukemia (AML)

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002892-30-DE

Enrollment

220

Registered

2015-11-03

Start date

2016-04-14

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with acute myeloid leukemia MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864

Interventions

Product Name: BI 836858 Product Code: - Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: - CAS Number: - Current Sponsor code: BI 836858 Other descriptive name: CD33 MON

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Phase I Dose Escalation: a.Male or female patients >/= 18 years of age with relapsed or refractory AML b.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 2)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 =65 years) yes F.1.3.1 Number of subjects for this age range 165

Exclusion criteria

Exclusion criteria: 1) Acute promyelocytic leukemia (APL, French-American-British (FAB) subtype M3), according to WHO classification 2) Patients who are candidates for allogeneic stem cell transplantation. 3) Active chronic graft versus host disease requiring immunosuppressive treatment 4) Prior treatment with a hypomethylating agent (this also includes prior MDS treatment with decitabine or azazitidine) 5) Prior treatment with Cluster of differentiation 33 (CD33) antibody

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase I Dose Escalation: To determine the maximum tolerated dose (MTD) and the recommended dose for Phase I Extension and to investigate the safety, pharmacokinetics (PK) and efficacy of BI 836858 in combination with decitabine in patients >/= 65 years of age with previously untreated acute myeloid leukemia (AML) and considered ineligible for standard intensive therapy, or patients >/= 18 years of age with refractory or relapsed AML. Phase I Extension: To collect additional data on safety, PK and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine in patients = 65 years of age with previously untreated AML and considered ineligible for standard intensive therapy. Phase II: To investigate efficacy, safety and PK of BI 836858 in combination with decitabine compared to decitabine monotherapy in patients >/= 65 years of age with previously untreated AML and considered ineligible for standard intensive therapy. ;Secondary Objective: The secondary endpoint of the Phase I part of this trial is objective response (Complete Remission/ Complete Remission with incomplete blood count recovery). Secondary endpoints of the Phase II part of this trial are Event-free survival (EFS), Relapse-free survival (RFS), Remission duration and Time to remission.;Primary end point(s): 1: Phase I: MTD of BI 836858 in combination with decitabine 2: Phase I: Number of patients with dose limiting toxicity (DLT(s)) during first treatment cycle 3: Phase II:Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi) ;Timepoint(s) of evaluation of this end point: 1: 12 months 2: 12 months 3: 30 months	—

Measure

Time frame

Main Objective: Phase I Dose Escalation: To determine the maximum tolerated dose (MTD) and the recommended dose for Phase I Extension and to investigate the safety, pharmacokinetics (PK) and efficacy of BI 836858 in combination with decitabine in patients >/= 65 years of age with previously untreated acute myeloid leukemia (AML) and considered ineligible for standard intensive therapy, or patients >/= 18 years of age with refractory or relapsed AML. Phase I Extension: To collect additional data on safety, PK and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine in patients = 65 years of age with previously untreated AML and considered ineligible for standard intensive therapy. Phase II: To investigate efficacy, safety and PK of BI 836858 in combination with decitabine compared to decitabine monotherapy in patients >/= 65 years of age with previously untreated AML and considered ineligible for standard intensive therapy. ;Secondary Objective: The secondary endpoint of the Phase I part of this trial is objective response (Complete Remission/ Complete Remission with incomplete blood count recovery). Secondary endpoints of the Phase II part of this trial are Event-free survival (EFS), Relapse-free survival (RFS), Remission duration and Time to remission.;Primary end point(s): 1: Phase I: MTD of BI 836858 in combination with decitabine 2: Phase I: Number of patients with dose limiting toxicity (DLT(s)) during first treatment cycle 3: Phase II:Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi) ;Timepoint(s) of evaluation of this end point: 1: 12 months 2: 12 months 3: 30 months

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Secondary

Measure	Time frame
Secondary end point(s): 1: Phase I: Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi) 2: Phase II: - Event free survival (EFS) 3: Phase II: - Relapse free survival (RFS) 4: Phase II: - Remission duration 5: Phase II: - Time to remission ;Timepoint(s) of evaluation of this end point: 1: 30 months 2: 30 months 3: 30 months 4: 30 months 5: 30 months	—

Measure

Time frame

Secondary end point(s): 1: Phase I: Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi) 2: Phase II: - Event free survival (EFS) 3: Phase II: - Relapse free survival (RFS) 4: Phase II: - Remission duration 5: Phase II: - Time to remission ;Timepoint(s) of evaluation of this end point: 1: 30 months 2: 30 months 3: 30 months 4: 30 months 5: 30 months

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Countries

Germany, Italy, Spain, United States

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com+1-800-243-0127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026