Clinical Trial: Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open-Label Single-Arm Pilot Study of Deferasirox (Exjade®) in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload
Brief Summary:
This study has been designed to establish the efficacy and safety of deferasirox in patients with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant (HSCT).
The purpose of this study is to assess the mean change in serum ferritin after 52 weeks of treatment with deferasirox, in patients with iron overload (defined with serum ferritin levels ≥ 1000 ng/ml and receiving > 20 RBC concentrates) after allogeneic HSCT.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Mean change in serum ferritin [ Time Frame: after 52 weeks of treatment with deferasirox ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mean change in the no. of sideroblasts, assessed by Perls staining [ Time Frame: after 52 weeks of treatment with deferasirox ]
- Mean change in liver iron concentration (LIC), assessed by liver MRI. [ Time Frame: after 52 weeks of treatment with deferasirox ]
- Incidence of chronic graft-versus-host disease ("limited" or "extensive", according to Shulman criteria) [ Time Frame: up to 52 weeks of study ]
- Incidence of infections (bacterial, viral, or fungal) [ Time Frame: up to 52 weeks of study ]
- Incidence of venous occlusive disease during the study [ Time Frame: up to 52 weeks of study ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: March 30, 2011
Date Started: December 2008
Date Completion:
Last Updated: April 27, 2012
Last Verified: April 2012
