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

Primary Purpose

Leukemia, Myeloid, Acute

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Decitabine
BI 836858
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 </=2 at screening Further inclusion criteria apply.

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. Phase I extension and Phase II only:

    Prior treatment with a hypomethylating agent, such as prior treatment for Myelodysplastic Syndrome (MDS).

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

Sites / Locations

  • Mayo Clinic Cancer Center
  • Northwestern University
  • Northwell Health
  • The Ohio State University Wexner Medical Center
  • Universitätsklinikum Augsburg
  • Vivantes Netzwerk für Gesundheit GmbH
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Universitätsklinikum Hamburg-Eppendorf
  • Universitätsklinikum Jena
  • Universitätsklinikum Münster
  • A.O. Spedali Civili di Brescia
  • Hospital Vall d'Hebron
  • Hospital Clínic de Barcelona
  • Hospital Politècnic La Fe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Phase I: Dose Escalation

Phase I: Extension

Phase II: Arm 1

Phase II: Arm 2

Arm Description

Combination treatment of decitabine with escalating doses of BI 836858

Cohort A treated with BI 836858 plus intensive decitabine treatment schedule. Followed by Cohort B treated with BI 836858 plus standard decitabine treatment schedule.

Combination treatment of decitabine with BI 836858

Monotherapy treatment with decitabine (standard of care treatment)

Outcomes

Primary Outcome Measures

Phase I: Number of patients with dose limiting toxicity (DLT(s)) during first treatment cycle
Phase II:Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi)
Phase I: MTD of BI 836858 in combination with decitabine

Secondary Outcome Measures

Phase II: Event free survival (EFS)
Phase II: Relapse free survival (RFS)
Phase II: Remission duration
Phase II: Time to remission
Phase I: Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi)

Full Information

First Posted
December 15, 2015
Last Updated
January 26, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02632721
Brief Title
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2016 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
January 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Phase I Dose Escalation: Open-label, single-arm, dose escalation - To determine the maximum tolerated dose (MTD) and the recommended dose for Phase I Extension (RExP1D) Phase I Extension: Open-label, two consecutive groups (cohort A and B) - To collect additional data on safety, pharmacokinetics and efficacy and to decide if the RExP1D will become the Recommended Phase II Dose (RP2D) Phase II: Open-label, two-arm randomized - To investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase I: Dose Escalation
Arm Type
Experimental
Arm Description
Combination treatment of decitabine with escalating doses of BI 836858
Arm Title
Phase I: Extension
Arm Type
Experimental
Arm Description
Cohort A treated with BI 836858 plus intensive decitabine treatment schedule. Followed by Cohort B treated with BI 836858 plus standard decitabine treatment schedule.
Arm Title
Phase II: Arm 1
Arm Type
Experimental
Arm Description
Combination treatment of decitabine with BI 836858
Arm Title
Phase II: Arm 2
Arm Type
Other
Arm Description
Monotherapy treatment with decitabine (standard of care treatment)
Intervention Type
Drug
Intervention Name(s)
Decitabine
Intervention Type
Drug
Intervention Name(s)
BI 836858
Primary Outcome Measure Information:
Title
Phase I: Number of patients with dose limiting toxicity (DLT(s)) during first treatment cycle
Time Frame
12 months
Title
Phase II:Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi)
Time Frame
30 months
Title
Phase I: MTD of BI 836858 in combination with decitabine
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Phase II: Event free survival (EFS)
Time Frame
60 months
Title
Phase II: Relapse free survival (RFS)
Time Frame
60 months
Title
Phase II: Remission duration
Time Frame
60 months
Title
Phase II: Time to remission
Time Frame
60 months
Title
Phase I: Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi)
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 </=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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Universitätsklinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Vivantes Netzwerk für Gesundheit GmbH
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
A.O. Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com
Description
Related Info

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

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