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Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
Bu çalışma, düşük veya orta riskli Miyelodisplastik Sendrom (Myelodysplastic Syndrome, MDS) hastalarında sık kan nakline bağlı gelişen demir yüklenmesinin (demir fazlalığı) tedavisinde Deferasiroks ilacını inceliyor. En az 30 kez kan nakli almış, ferritin düzeyi yüksek 18 yaş üstü hastalar dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Male or female patients with low or intermediate (INT-1) risk MDS * Patients can be EITHER naïve to iron chelation OR have had prior treatment with deferoxamine (DFO). * Age greater than or equal to 18 years * Availability of transfusion records for the 12 weeks prior to registration * A lifetime minimum of 30 previous packed red blood cell transfusions * Availability of at least three CBC values (pretransfusion) during the 12 weeks prior to registration * Serum Ferritin: For entry into the screening period, serum ferritin ≥ 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year. Serum ferritin ≥ 1000 ng/mL at screening via the central lab. * Life expectancy ≥ 6 months * Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months) * Able to provide written informed consent Exclusion Criteria: * Serum creatinine above the upper limit of normal * Alanine aminotransferase (ALT) \> 500 U/L during screening * Clinical or laboratory evidence of active Hepatitis B or C * Urinary protein/creatinine ratio \> 0.5 mg/mg * History of HIV positive test result (ELISA or Western blot) * Eastern Cooperative Oncology Group (ECOG) Performance Status \> 2 * Patients with uncontrolled systemic hypertension * Unstable cardiac disease not controlled by standard medical therapy * Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation * Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment * Pregnancy or breast feeding * Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days * Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug * History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative