Safety of SP-420 in the Treatment of Transfusional Iron Overload (NCT04741542) | Clinical Trial Compass
TerminatedPhase 1
Safety of SP-420 in the Treatment of Transfusional Iron Overload
Stopped: Study is on hold by FDA in the US.
United States2 participantsStarted 2021-03-09
Plain-language summary
This study enrolls patients with myelodysplastic syndrome (MDS) and myelofibrosis (MFS), with transfusional iron overload and treats them with the investigational iron chelator, SP-420. SP-420 may be better tolerated and safer than commercially available iron chelators. Iron chelation therapy (ICT) has been shown to improve outcomes in iron overload, but adherence is poor due to problems related to ease of administration, tolerability, and safety.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18
✓. Diagnosis of MDS or MF with transfusional iron overload
✓. Patients with MDS, will include only those with MDS Revised international prognostic scoring system (IPSS-R) risk group of intermediate, high, or very high.
✓. Patients with MF, will include only those with Dynamic International Prognostic Scoring System-Plus (DIPSS=Plus) risk category of intermediate-1, intermediate-2, and high risk.
✓. Patients with sickle cell disease and transfusional iron overload
✓. Not appropriate for other iron chelation therapy, per physician
✓. Received 10 or more units of packed red blood cells in the preceding 24 months and remains red cell transfusion dependent
✓. ECOG ≤ 3
Exclusion criteria
✕. History of kidney disease including the renal Fanconi syndrome
What they're measuring
1
Number of adverse events
Timeframe: 28 Days
2
Completion at original dose
Timeframe: 28 Days
Trial details
NCT IDNCT04741542
SponsorThe University of Texas Health Science Center at San Antonio
. Proteinuria on urine dipstick greater than trace positive
✕. Pregnant, intending to become pregnant during the study, or breastfeeding
✕. Receiving another investigational drug within 30 days or 3 half-lives of the discontinued investigational agent, whichever is greater, of signing consent
✕. History of significant hepatic impairment, defined by Child-Pugh class C
✕. Active hepatitis B or C disease, evidenced by positive viral PCR
✕. Symptomatic heart failure
✕. Receiving active cytotoxic chemotherapy or radiation therapy for a second malignancy (hormonal therapy or topical therapy for squamous cell/basal cell cutaneous tumors are allowed). Treatment of the underlying hematologic malignancy with azacytidine, decitabine, venetoclax, lenalidomide, or ruxolitinib is permitted. Treatment with the supportive care agents luspatercept or erythropoietin agonists is permitted.