Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Anti-Bacterial Agents

Cytarabine

Fludarabine

Fludarabine phosphate

Iron

Daunorubicin

Lenograstim

Antibiotics, Antitubercular

Idarubicin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Patients randomized to this arm will receive an FDA-approved drug or combination of drugs predicted to have a therapeutic effect based on their individual MDS disease genetic profile by a computational biology simulation software program. The specific drug or combination of drugs that a patient on this arm will receive will be decided jointly by a molecular oncology board comprised of physicians, pharmacists, and nurse coordinators and the treating physician. Patients will receive a minimum of 2 months and a maximum of 4 months of treatment with the selected drug or combination of drugs.

Patients randomized to this arm will receive either one of three standard of care treatment regimens of the treating physician's choice (low-dose cytarabine, 7 + 3 induction, or FLAG induction) or supportive care alone. Patients will receive a minimum of 2 months and a maximum of 4 months of the selected treatment regimen or of supportive care alone.

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).

FDA-approved drug or combination of drugs

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.

FLAG 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.

7 + 3 induction

Patients will receive 20 mg/m2 per day subcutaneously of cytarabine for 10 days every 28 days.

Low-dose cytarabine

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.

Supportive care alone

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.

Computational biology simulations software

Christopher Cogle, MD

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).

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

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

Difference in overall response (number of patients who achieve complete response, partial response, stable disease, or hematologic improvement per IWG 2006 criteria) between patients treated with computational biology-informed therapy vs. those treated with standard of care regimens

Difference in safety and feasibility, as measured by CTCAE v4.0 criteria, between patients treated with computational biology-informed treatment and those who receive a standard of care regimen

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
iCare 2: Personalized Genomic Mutation Informed Treatment of Patients With Myelodysplastic Syndromes	NCT03446638	Myelodysplastic...	FDA-approved dr... FLAG induction 7 + 3 induction Low-dose cytara... Supportive care... Computational b...	18 Years - 99 Years	University of Florida
iCare 2: Personalized Genomic Mutation Informed Treatment of Patients With Myelodysplastic Syndromes	NCT03446638	Myelodysplastic...	FDA-approved dr... FLAG induction 7 + 3 induction Low-dose cytara... Supportive care... Computational b...	18 Years - 99 Years	University of Florida

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