Trial to Find and Investigate a Safe Dose of F16IL2 and BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

December 2, 2016

Primary Completion Date

March 26, 2020

Study Completion Date

March 26, 2020

Conditions
Acute Myeloid Leukemia (AML) Relapse
Interventions
DRUG

F16IL2

F16IL2 dose escalation with provisional doses of 10, 20 and 30 Mio IU on Day 1, 8, 15 and 22 of each cycle through a rate-controlled intravenous infusion of 3 hours

DRUG

BI 836858

BI 836858 dose escalation with provisional doses of 10, 20, 40, 80 and 160 mg on days 3, 10, 17 and 24 of each cycle through a rate-controlled intravenous infusion up to 5 hours

Trial Locations (2)

Unknown

University Medical Center Freiburg, Freiburg im Breisgau

Münster University Hospital, Münster

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Boehringer Ingelheim

INDUSTRY

lead

Philogen S.p.A.

INDUSTRY

NCT03207191 - Trial to Find and Investigate a Safe Dose of F16IL2 and BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation | Biotech Hunter | Biotech Hunter