Overview

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

Status:
Active, not recruiting
Trial end date:
2021-11-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Azacitidine
Decitabine
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 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.