Acute Myeloid Leukemia Clinical Trial

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

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.

View Eligibility Criteria

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
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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

49

Study ID:

NCT02632721

Recruitment Status:

Active, not recruiting

Sponsor:

Boehringer Ingelheim

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There are 14 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

49

Study ID:

NCT02632721

Recruitment Status:

Active, not recruiting

Sponsor:


Boehringer Ingelheim

How clear is this clinincal trial information?

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