Combination study of deferasirox and erythropoietin in patients with low- and int-1-riskmyelodysplastic syndrome.

Phase 1

• Conditions: low- and int-1-risk myelodysplastic syndrome; MedDRA version: 16.1Level: LLTClassification code 10028534Term: Myelodysplastic syndrome NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-000981-12-IT
• Lead Sponsor: OVARTIS FARMA S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-13
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Patients with low- and Int-1-risk myelodysplastic syndrome
? Documented diagnosis of the following:
? Myelodysplastic syndrome lasting = 3 months and < 2 years
? Disease must not be secondary to treatment with radiotherapy, chemotherapy,
and/or immunotherapy for malignant or autoimmune diseases
? Hemoglobin < 10 g/dL and = 8 g/dL (Patients who require RBC
transfusions must not be enrolled in the study. Patients must be withdrawn from the study anytime when transfusion as rescue therapy is needed)
? History of transfusions < 10 RBC units
? 300 ng/mL < serum ferritin < 1,000 ng/mL
? Endogenous erythropoietin levels < 500 units/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58

Exclusion Criteria

? Patients with MDS with isolated del(5q)
? Patients who had received prior EPO treatment or other recombinant growth factors regardless of the outcome (Patient who had received prior EPO treatment or other recombinant growth factors for less than 4 weeks and not within 3 months before screening without a documented response are allowed)
? Patients receiving steroids or immunosuppressive therapy for the
improvement of hematological parameters (steroid for adrenal failure, and intermittent dexamethasone as antiemetic are allowed).
? B12 and folate deficient patients (patients could be rescreened after successful
therapy of B12 and folate deficiency)
? Uncontrolled seizures or uncontrolled hypertension

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified