A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
Completed · Phase 1/Phase 2
Conditions studied: Leukemia, Myeloid, Acute
In brief
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.
Key facts
- Study ID
- NCT02632721
- Run by
- Boehringer Ingelheim
- People needed
- 49
- Starts
- 2016-06-16
- Expected to finish
- 2023-01-16
- Last updated by the study team
- 2024-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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.
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic Cancer Center — Jacksonville, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- Northwell Health — Lake Success, New York, United States
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Universitätsklinikum Augsburg — Augsburg, Germany
- Vivantes Netzwerk für Gesundheit GmbH — Berlin, Germany
- Universitätsklinikum Carl Gustav Carus Dresden — Dresden, Germany
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
- Universitätsklinikum Jena — Jena, Germany
- Universitätsklinikum Münster — Münster, Germany
- A.O. Spedali Civili di Brescia — Brescia, Italy
- Hospital Vall d'Hebron — Barcelona, Spain
- Hospital Clínic de Barcelona — Barcelona, Spain
- Hospital Politècnic La Fe — Valencia, Spain
Full record on ClinicalTrials.gov
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