Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00673608
Other study ID # CICL670AAU01
Secondary ID
Status Completed
Phase Phase 4
First received May 5, 2008
Last updated February 20, 2017
Start date November 2007
Est. completion date September 2011

Study information

Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 2 cohorts of patients


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- Male or female WITH haemoglobinopathy, Myelodysplastic Syndromes or other inherited or acquired anaemia (e.g. MPD, Diamond-blackfan anaemia and other rare anaemias) patients = 18 years and weighing >40kg.

- Lifetime minimum of > 20 units of packed red blood cell transfusions

- Normal or minimally abnormal cardiac function

Exclusion criteria:

- Contraindication to MRI scans

- High risk myelodysplastic syndromes patients and patients with other haematological and non-haematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease

- Patients with uncontrolled high blood pressure

- An organ transplant less than 3 months previously

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design


Intervention

Drug:
deferasirox
Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily

Locations

Country Name City State
Australia Novarts Investigative Site Adelaide
Australia Novarts Investigative Site Brisbane
Australia Novarts Investigative Site Melbourne
Australia Novarts Investigative Site Sydney

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks. 12 months
Secondary Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks. 12 months
Secondary Change in cardiac T2* from baseline to 53 weeks in the MDS and other anaemias subgroup, compared to the thalassaemia subgroup. 12 months
Secondary Changes in serum ferritin from baseline values to 53 weeks. 12 months
Secondary Changes in Liver Iron Content (LIC) by MRI from baseline values to 53 weeks 12 months
Secondary The relationship between the dosing regimen of Exjade® and changes in cardiac T2* and LIC R2 MRI 12 months
Secondary Changes in markers of iron load levels between baseline and 53 weeks. 12 months
Secondary The safety and tolerability of deferasirox therapy from baseline to 53 weeks 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Terminated NCT04313881 - Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) Phase 3
Recruiting NCT05088356 - Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft Phase 1
Recruiting NCT04003220 - Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Active, not recruiting NCT03755414 - Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation Phase 1
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Terminated NCT04866056 - Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF. Phase 1/Phase 2
Recruiting NCT04701229 - Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes
Suspended NCT04485065 - Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS Phase 1
Recruiting NCT04174547 - An European Platform for Translational Research in Myelodysplastic Syndromes
Enrolling by invitation NCT04093570 - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers Phase 2
Completed NCT02508870 - A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes Phase 1
Completed NCT04543305 - A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies Phase 1
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Recruiting NCT05365035 - A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts Phase 2
Recruiting NCT06008405 - Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy Phase 1
Not yet recruiting NCT05969821 - Clonal Hematopoiesis of Immunological Significance
Withdrawn NCT05170828 - Cryopreserved MMUD BM With PTCy for Hematologic Malignancies Phase 1