NCT03446638

iCare 2: Personalized Genomic Mutation Informed Treatment of Patients With Myelodysplastic Syndromes

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This open-label, randomized, parallel group phase II study will investigate the efficacy of computational biology-informed treatment vs. standard of care treatment for patients with relapsed or refractory myelodysplastic syndromes (MDS).

Detailed description

It is hypothesized that personalized treatment informed by computational biology simulation technology will improve treatment outcomes for patients with relapsed or refractory MDS.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	FDA-approved drug or combination of drugs	Patients assigned to this arm will receive an FDA-approved drug or combination of drugs. Dosing and treatment schedule will follow the package insert for the selected drug(s).
DRUG	FLAG induction	Patients will receive 30 mg/m2 per day intravenously of fludarabine for 5 days and 2000 mg/m2 per day intravenously of cytarabine for 5 days. 5 mg/kg per day of granulocyte colony stimulating factor (G-CSF) may be given subcutaneously beginning on Day 1 of each treatment until absolute granulocyte count \> 500/ microliter for 3 days.
DRUG	7 + 3 induction	Patients will receive 100-200 mg/m2 per day intravenously of cytarabine for 7 days, plus either 45-60 mg/m2 per day intravenously of daunorubicin or 9-12 mg/m2 per day intravenously of idarubicin for 3 days.
DRUG	Low-dose cytarabine	Patients will receive 20 mg/m2 per day subcutaneously of cytarabine for 10 days every 28 days.
OTHER	Supportive care alone	Patients will receive one or more of the following: blood product transfusions, antibiotics, granulocyte colony-stimulating factor (G-CSF), erythropoietic stimulating factors, and iron chelation.
DEVICE	Computational biology simulations software	Genetic testing results for each patient randomized to this arm will be used by a computational biology simulations software program to generate a personalized map of dysregulated metabolic pathways contributing to the patient's disease. This map will then be used to digitally screen for potentially therapeutic FDA-approved drugs or drug combinations to target the dysregulated metabolic pathways.

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-08-01
• Completion: 2022-09-01
• First posted: 2018-02-27
• Last updated: 2019-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study