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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: City of Hope Medical Center

Current Primary Outcome:

  • Safety and tolerability of low dose deferasirox in the post allogeneic hematopoietic stem cell transplant setting [ Time Frame: Assessed through 6 months from the start of treatment ]
    Safety and tolerability will be assessed based upon laboratory evaluations, physical examinations, vital signs and monitoring for adverse events.
  • Percentage of patients with elevated labile plasma iron (LPI) above threshold (0.5 umol/L) [ Time Frame: At baseline ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ability of deferasirox to suppress LPI below threshold [ Time Frame: Assessed through 6 months from the start of treatment ]
  • Ability of deferasirox to lower serum ferritin levels [ Time Frame: Assessed through 6 months from the start of treatment ]
  • Correlation of LPI with serum ferritin [ Time Frame: Assessed through 6 months from the start of treatment ]


Original Secondary Outcome: Same as current

Information By: City of Hope Medical Center

Dates:
Date Received: July 6, 2010
Date Started: July 2010
Date Completion:
Last Updated: July 16, 2012
Last Verified: July 2012