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

NCT03207334 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-10-22

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Maxim Norkin, MD, PhD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2021-01-31
Completion
2022-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03207334 on ClinicalTrials.gov