A study to find and investigate a safe dose of BI 836858 in combination with decitabine for patients with acute myeloid leukemia (AML)

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; patients with acute myeloid leukemia; MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864

• Registration Number: EUCTR2015-002892-30-IT
• Lead Sponsor: BOEHRINGER-INGELHEIM ITALIA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-05
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1)Phase I Dose Escalation:
a.Male or female patients >/= 18 years of age with relapsed or
refractory AML
b.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 at screening
5)Signed and dated written informed consent (including consent for biomarker and
genetic testing; refer to Section 8.1) by the start date of the Screening Visit in
accordance with GCP and local legislation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 145

Exclusion Criteria

1) Acute promyelocytic leukemia (APL, French-American-British (FAB)
subtype M3), according to WHO classification
2) Patients who are candidates for allogeneic stem cell transplantation.
3) Active chronic graft versus host disease requiring immunosuppressive
treatment
4) Prior treatment with a hypomethylating agent (this also includes prior
MDS treatment with decitabine or azazitidine)
5) Prior treatment with Cluster of differentiation 33 (CD33) antibody

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified