Clinical Trials Directory

Trials / Terminated

TerminatedNCT01159067

Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload

Deferasirox Treatment and Labile Plasma Iron in Iron Overloaded Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
1 (actual)
Sponsor
City of Hope Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have undergone hematopoietic stem cell transplant and have iron overload. PURPOSE: This pilot clinical trial studies safety and tolerability of deferasirox in hematopoietic stem cell transplant recipients who have iron overload. Effect of low dose deferasirox on labile plasma iron is also examined.

Detailed description

PRIMARY OBJECTIVES: I. To determine labile plasma iron (LPI) levels in iron overloaded patients after allogeneic Hematopoietic Stem Cell Transplantation (HSCT). II. To determine safety and tolerability of low dose deferasirox in the post allogeneic HSCT setting. SECONDARY OBJECTIVES: I. To determine ability of deferasirox to suppress LPI in allogeneic HSCT patients with serum ferritin over 1500 ng/ml. II. To determine prevalence of elevated LPI in allogeneic HSCT recipients with serum ferritin over 1500 ng/ml. III. To determine ability of low dose deferasirox to lower serum ferritin during the treatment period. IV. To correlate LPI with serum ferritin in allogeneic HSCT recipients with serum ferritin over 1500 ng/ml. OUTLINE: Patients receive deferasirox at 10 mg/kg once daily for 6 months in the absence of unacceptable toxicity. Labile plasma iron will be measured at baseline and at weeks 4, 12, and 24. Side effects of deferasirox will be recorded.

Conditions

Interventions

TypeNameDescription
DRUGdeferasiroxGiven orally

Timeline

Start date
2010-07-01
Primary completion
2011-08-09
Completion
2011-08-09
First posted
2010-07-09
Last updated
2019-06-18
Results posted
2019-05-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01159067. Inclusion in this directory is not an endorsement.

Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload (NCT01159067) · Clinical Trials Directory