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

NCT00602446 | Terminated Phase 2 Results DMC

• 4 other identifiers: CDR0000584690UMN-2007LS065UMN-MT2007-11RNOVARTIS-CICL670AUS12
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

iron overload

Outcome Measures

Primary Outcomes (1)

• Number of Patients Not Completing Treatment

  Number of patients who discontinued deferasirox during 6 month daily treatment due to drug related toxicity

  6 Months

Secondary Outcomes (1)

• Reduction in Liver Iron Concentration After Study Drug

  6 Months

Study Arms (1)

Deferasirox Treated

EXPERIMENTAL

Includes patients that were treated with deferasirox for 6 months.

Drug: deferasirox

Interventions

deferasirox DRUG

20 mg/kg once daily orally for 6 months

Also known as: Exjade

Deferasirox Treated

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Iron Overload; Leukemia; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Myelodysplastic Syndromes; Neuroblastoma; Ovarian Neoplasms

Interventions

Deferasirox

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Bone Marrow Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Linda J. Burns, MD
• Organization: Masonic Cancer Center, University of Minnesota

burns019@umn.edu

612-624-8144

Study Officials

• Linda J. Burns, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: January 28, 2008
• Study Start: August 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 28, 2017
• Results First Posted: March 30, 2010

Record last verified: 2017-12

Locations

US (1)