NCT03207334

iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004)

A Phase II, Open-Label Clinical Efficacy Study Defining Genomic Signatures That Correlate With Midostaurin Response in Relapsed or Refractory Acute Myeloid Leukemia (AML)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, single arm study of midostaurin in patients with relapsed or refractory AML.

Detailed description

Clinical trials have shown that the multi-kinase inhibitor midostaurin improves survival in patients with AML. The main objective of this study is to investigate its effect (in conjunction with cytarabine) on progression free survival, as well as overall survival and morphologic response rate in patients with relapsed or refractory AML. This study will also attempt to identify specific populations of patients with relapsed or refractory AML who best respond to treatment with midostaurin to enhance treatment planning.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Midostaurin	Induction Phase: 50 mg orally twice daily beginning on day 7 and ending 48 hours prior to beginning the consolidation phase Consolidation Phase: 50 mg orally twice daily beginning on Day 6 and ending 48 hours prior to either the start of the next cycle or beginning conditioning therapy for allogenic stem cell transplant.
DRUG	Cytarabine	Induction Phase: 3 g/m2 (patients 18-65 years old) or 1 g/m2 (patients \> 65 years old or those with co-morbidities precluding a higher dose) by vein over 3 hours every 12 hours on Days 1-6. Consolidation Phase: 3 g/m2 (patients 18-65 years old) or 1 g/m2 (patients \> 65 years old or those with co-morbidities precluding a higher dose) by vein over 3 hours every 12 hours on Days 1, 3, and 5 of each cycle.

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-01-01
• Completion: 2022-01-01
• First posted: 2017-07-02
• Last updated: 2018-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study