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

Phase 2

Terminated

• Conditions: Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Atypical Chronic Myeloid Leukemia, BCR-ABL Negative; de Novo Myelodysplastic Syndromes; Iron Overload; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Chronic Eosinophilic Leukemia
• Interventions: Drug: deferasirox

• Registration Number: NCT01159067
• Lead Sponsor: City of Hope Medical Center

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 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-09
• Primary Completion: 2011-08-09
• Study Completion: 2011-08-09
• Status Verified: 2017-11
• Results First Submitted: 2019-05-02
• Results First Submitted QC: 2019-05-02
• Results First Posted: 2019-05-29
• Last Update Submitted: 2019-06-07
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	deferasirox	Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)	At baseline

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Serum Ferritin Level Lower Than 1500 ng/mL After Treatment	Assessed through 6 months from the start of treatment	Number of patients, whose Serum Ferritin levels are lower than 1500 ng/mL at two consecutive study visits. Serum Ferritin levels are measured at screening (baseline), week 4, 8, 12, 16, 20, 24 and end of study.
Correlation of LPI With Serum Ferritin	Assessed through 6 months from the start of treatment	Both LPI and Serum Ferritin levels are measured at screening (baseline), week 4, 12, 24 and end of study. The correlation between the levels of LPI and Serum Ferritin at screening, week 4, 12, 24 and end of study will be examined and plotted.
Number of Patients With LPI Below 0.5 Umol/L After Treatment	Assessed through 6 months from the start of treatment	In patients with LPI values above threshold 0.5umol/L at baseline, number of patients had LPI suppressed below this value after treatment. Measurement of LPI is done on plasma specimens.

Trial Locations

Locations (1)

City of Hope; 🇺🇸 Duarte, California, United States