Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant

NCT ID: NCT00602446

Last Updated: 2017-12-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-12-31

Brief Summary

RATIONALE: Deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant.

PURPOSE: This phase II trial is studying the side effects and how well deferasirox works in treating patients with iron overload after donor stem cell transplant.

Detailed Description

OBJECTIVES:

Primary

• To evaluate the safety of deferasirox given over 6 months in reducing liver iron concentration in patients with transfusional iron overload after undergoing allogeneic hematopoietic stem cell transplantation.

Secondary

• To evaluate the efficacy of deferasirox in reducing liver iron overload in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral deferasirox once daily for 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed at 4 weeks.

Conditions

Breast Cancer; Iron Overload; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Neuroblastoma; Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Deferasirox Treated

Includes patients that were treated with deferasirox for 6 months.

Group Type: EXPERIMENTAL

deferasirox

Intervention Type: DRUG

20 mg/kg once daily orally for 6 months

Interventions

deferasirox

20 mg/kg once daily orally for 6 months

Intervention Type: DRUG

Other Intervention Names

Exjade

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of iron overload, defined as serum ferritin > 1,000 ng/mL and liver iron concentration ≥ 5 mg iron/g on tissue proton transverse relaxation rates Magnetic Resonance Imaging (MRI)
• Underwent prior allogeneic hematopoietic stem cell transplantation (HSCT) using either myeloablative or reduced-intensity conditioning at least 12 months ago
• No evidence of relapse or progression of the primary disease for which allogeneic HSCT was performed
• Patients who have become red-cell transfusion independent (i.e., no red cell transfusions within the past 3 months) as well as patients who require red cell transfusions are eligible
• Meets one of the following criteria:

• Ineligible for phlebotomy (hemoglobin < 11 g/dL, poor intravenous access, or unable to undergo phlebotomy every 4 weeks)
• Have failed treatment with phlebotomy (serum ferritin > 50% of baseline after 3 months of phlebotomy)
• Refused phlebotomy
• ECOG performance status of 0-2
• Life expectancy ≥ 6 months
• Adequate renal function defined as serum creatinine < or = 1.6 mg/dL and creatinine clearance of > or = 60 ml/min calculated using the Crockcroft-Gault formula on 2 occasions within 30 days of enrollment
• Sexually active men and women must use an effective method of contraception. Alternatively, women must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal.
• Must be able to give written informed consent.
• Prior therapy with deferoxamine allowed provided it was completed ≥ 12 months ago

Exclusion Criteria

• Contraindication for performing MRI or inability to undergo MRI because of claustrophobia or weight (>350 pounds).
• Inability to take medications orally.
• Uncontrolled bacterial, viral, or fungal infection
• ANC ≥ 1,000/mm³
• Hemoglobin ≥ 8.0 g/dL
• Platelet count ≥ 50,000/mm³
• Aspartate aminotransferance (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal
• Less than 4 weeks since prior and no concurrent systemic investigational drug
• Less than 7 days since prior and no concurrent topical investigational drug. Concurrent non-investigational medications needed to treat concomitant medical conditions are allowed, with the exception of other chelating agents. Concurrent growth factors such as epoetin alfa, darbepoetin alfa, filgrastim (G-CSF), and sargramostim (GM-CSF) allowed. Concurrent irradiated packed red-cell and platelet transfusions allowed as clinically indicated. Concurrent low-doses of vitamin C supplements (≤ 200 mg/day) allowed.
• Concurrent iron supplements or multivitamins with iron.
• Aluminum-containing antacid therapies may not be taken simultaneously with deferasirox, but may be taken 2 hours before or after administration of deferasirox
• On dialysis or status post-renal transplantation
• Pregnant or nursing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda J. Burns, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

UMN-2007LS065

Identifier Type: OTHER

Identifier Source: secondary_id

UMN-MT2007-11R

Identifier Type: OTHER

Identifier Source: secondary_id

NOVARTIS-CICL670AUS12

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000584690

Identifier Type: -

Identifier Source: org_study_id