Status:
WITHDRAWN
iCare 2: Personalized Genomic Mutation Informed Treatment of Patients With Myelodysplastic Syndromes
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Gateway for Cancer Research
Cellworks Group Inc.
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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 refrac...
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.
Eligibility Criteria
Inclusion
- Provide written informed consent
- Must be at least 18 years of age
- Diagnosis of MDS, as defined by World Health Organization (WHO) 2008, that has relapsed after any duration of time from last best response or is refractory to induction therapy (defined as 4 cycles of treatment with a hypomethylating agent, 2 cycles of lenalidomide, 1 cycle of low intensity chemotherapy, or 1 cycle of high intensity chemotherapy)
- ECOG performance status of 0-2
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) may participate, provided they meet the following conditions:
- Must agree to use physician-approved contraceptive methods (e.g., abstinence, intrauterine device, oral contraceptive, double barrier device) throughout the study and for 3 months following the last dose of study treatment; and
- Must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial
- Males with female partners of child-bearing potential must agree to use physician approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 6 months following the last dose of study treatment.
Exclusion
- Must not have acute myeloid leukemia (AML), as defined by WHO 2008
- Pregnant and nursing subjects are excluded because the effects of study treatments on a fetus or nursing child are unknown
- Must not have had treatment with any anti-cancer therapy (investigational or standard) within the previous 21 days prior to the first dose of study drug or less than full recovery (no worse than CTCAE v4.0 grade 1) from the clinically significant toxic effects of that treatment.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03446638
Start Date
May 1 2019
End Date
September 1 2022
Last Update
June 11 2019
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32608