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

A Phase I Study of the Tumor-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With the Anti-CD33 Antibody BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase I, open label, single arm, non-randomized, multicenter, prospective dose escalation study in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT).

Detailed description

The aim of the study is to determine a recommended dose for F16IL2 in combination with BI 836858 in AML relapse after alloHSCT and investigating safety and tolerability of the combination regimen. Dose escalation will be guided by a Bayesian logistic regression model (BLRM) with overdose control that will be fitted to binary toxicity outcomes. The estimate of parameters will be updated as data are accumulated using the BLRM. At the end of the dose escalation phase, the probability of toxicity at each dose combination level will be calculated to determine an estimate of the MTD. Once the MTD or a biological active dose has been defined, additional patients (up to 10) will be treated with F16IL2 and BI 836858 dosed at this dose combination in order to confirm the safety profile of the combination.

Conditions

• Acute Myeloid Leukemia (AML) Relapse

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-12-02
• Primary completion: 2020-03-26
• Completion: 2020-03-26
• First posted: 2017-07-02
• Last updated: 2022-04-20

Locations

2 sites across 1 country: Germany