A study of the benefit and safety of using the drug Deferasirox in patients with increased iron levels who have Myelodysplastic Syndromes

Phase 1

• Conditions: Iron overload in patients being treated for Myelodysplastic syndroms (MDS) by regular blood transfusions; MedDRA version: 14.1 Level: LLT Classification code 10068361 Term: MDS System Organ Class: 100000004864; MedDRA version: 14.1 Level: LLT Classification code 10040310 Term: Serum iron increased System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004559-38-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-07
• Study Completion: 2017-05-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 13

Inclusion Criteria

• At least 18 years old.
• Written informed consent.
• MDS with:
o Baseline haemoglobin concentration < 11 g/dl and clinically requiring red cell transfusion with a frequency of at least 2 units every 6 weeks for the receding 12 week period.
o Serum ferritin >300µg/l but <1000 µg/l in absence of ongoing inflammation (CRP < 3 x ULN)
o Serum creatinine <1.2 x ULN and/or creatinine clearance > 40 mls/min
o ALT or AST < 2.5 ULN
o IPSS Low/INT-1 previously untreated or having failed a therapeutic trial of erythropoetic stimulating agents (ESA) or other active MDS drug therapy, or alternatively lost their response to such therapy
o IPSS INT-2 with < 10% blasts and lacking a complex karyotype or monosomy 7 (and with stable blood counts from diagnosis to study entry).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

Exclusion Criteria

• Active treatment for MDS, including erythropoetic stimulating agents (ESA), 5-azacitidine, antilymphocyte globulin and low dose chemotherapy such as cytarabine during the trial and within the last 8 weeks
• Life expectancy of less than 1 year
• Known HIV positive
• Active infection
• Use of prior investigational agents within 6 weeks
• Pregnancy or lactation
•Other severe, concurrent medical illness that may affect the patients participation in the study, or psychiatric disorders
• Concurrent active or previous malignancy, within the last 3 years, – except controlled, localised prostate cancer on hormone therapy or basal cell carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ
• Ongoing inflammation as measured by CRP > 3 x ULN
• Serum creatinine >1.2 x ULN and/or creatinine clearance < 40 mls/min
• ALT or AST >2.5 ULN
• History of drug/alcohol abuse or non-compliance

Study & Design

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