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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:June 16, 2016
End Date:November 30, 2020
Contact:Boehringer Ingelheim Call Center
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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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

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.


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 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.
We found this trial at
6
sites
303 East Superior Street
Chicago, Illinois 60611
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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2 Stenglinstraße
Augsburg, 86156
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Augsburg,
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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Jacksonville, Florida 32224
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Jacksonville, FL
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Lake Success, New York 11042
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Lake Success, NY
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