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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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ClinicalTrials.gov Identifier: NCT02632721
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: Decitabine Drug: BI 836858 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 16, 2016
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020


Arm Intervention/treatment
Experimental: Dose Escalation Cohorts (Phase I)
Combination treatment of decitabine with escalating doses of BI 836858
Drug: Decitabine
Drug: BI 836858
BI 836858 weekly i.v. infusion

Experimental: Extension Cohorts (Phase I)
Combination treatment of decitabine with BI 836858 at MDT (Maximum Tolerated Dose)
Drug: Decitabine
Drug: BI 836858
BI 836858 weekly i.v. infusion

Experimental: Arm 1 (Phase II)
Combination treatment of decitabine with BI 836858 at R2PD (Recommended Phase II dose)
Drug: Decitabine
Drug: BI 836858
BI 836858 weekly i.v. infusion

Arm 2 (Phase II)
Monotherapy treatment with decitabine (standard of care treatment)
Drug: Decitabine



Primary Outcome Measures :
  1. Phase I: Number of patients with dose limiting toxicity (DLT(s)) during first treatment cycle [ Time Frame: 12 months ]
  2. Phase II:Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi) [ Time Frame: 30 months ]
  3. Phase I: MTD of BI 836858 in combination with decitabine [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Phase II: - Event free survival (EFS) [ Time Frame: 30 months ]
  2. Phase II: - Relapse free survival (RFS) [ Time Frame: 30 months ]
  3. Phase II: - Remission duration [ Time Frame: 30 months ]
  4. Phase II: - Time to remission [ Time Frame: 30 months ]
  5. Phase I: Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi) [ Time Frame: 30 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Further exclusion criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632721


Contacts
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Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, Florida
Mayo Clinic Cancer Center Recruiting
Jacksonville, Florida, United States, 32224
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Completed
Chicago, Illinois, United States, 60611
United States, New York
Northwell Health Recruiting
Lake Success, New York, United States, 11042
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Germany
Universitätsklinikum Augsburg Recruiting
Augsburg, Germany, 86156
Vivantes Netzwerk für Gesundheit GmbH Recruiting
Berlin, Germany, 10967
Universitätsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Universitätsklinikum Jena Recruiting
Jena, Germany, 07740
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Italy
A.O. Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Politècnic La Fe Recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02632721     History of Changes
Other Study ID Numbers: 1315.2
2015-002892-30 ( EudraCT Number )
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors