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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00602446
• Date of registration: 24/01/2008
• Primary sponsor: Masonic Cancer Center, University of Minnesota
• Public title: Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant
• Scientific title: Open-Label Single-Arm Pilot Study of Deferasirox (Exjade®) in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload
• Date of first enrolment: August 2007
• Target sample size: 4
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00602446
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Countries of recruitment

United States

Contacts

• Name: Linda J. Burns, MD
• Affiliation: Masonic Cancer Center, University of Minnesota

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Cancer

Iron Overload

Leukemia

Lymphoma

Multiple Myeloma and Plasma Cell Neoplasm

Myelodysplastic Syndromes

Neuroblastoma

Ovarian Cancer

Intervention(s)

Drug: deferasirox

Primary Outcome(s)

Number of Patients Not Completing Treatment [Time Frame: 6 Months]

Secondary Outcome(s)

Reduction in Liver Iron Concentration After Study Drug [Time Frame: 6 Months]

Secondary ID(s)

CDR0000584690

NOVARTIS-CICL670AUS12

UMN-2007LS065

UMN-MT2007-11R

Source(s) of Monetary Support

Please refer to primary and secondary sponsors