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Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00602446
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Cancer-Related Problem/Condition
Chronic Myeloproliferative Disorders
Gestational Trophoblastic Tumor
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Neuroblastoma
Ovarian Cancer
Testicular Germ Cell Tumor
Drug: deferasirox
Phase II

Genetics Home Reference related topics: aceruloplasminemia breast cancer hemophilia
MedlinePlus related topics: Breast Cancer Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma Neuroblastoma Ovarian Cancer
Drug Information available for: Deferasirox
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Open Label
Official Title: Open-Label Single-Arm Pilot Study of Deferasirox (Exjade®) in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of patients dropping out due to drug related toxicity over the course of treatment [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of all specific toxicities as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Efficacy as measured by reduction in liver iron concentration (LIC) after 6 months of the study drug compared to baseline [ Designated as safety issue: No ]
  • Variance of the measure of reduction of LIC [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: August 2007
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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 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)

      • Patients are considered unable to undergo phlebotomy if they need red-cell transfusions or recombinant epoetin alfa to maintain hemoglobin ≥ 11 g/dL
    • Have failed treatment with phlebotomy (serum ferritin > 50% of baseline after 3 months of phlebotomy)
    • Refused phlebotomy

PATIENT CHARACTERISTICS:

  • ECOG performance status of 0-2
  • Life expectancy ≥ 6 months
  • ANC ≥ 1,000/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 50,000/mm³
  • Serum creatinine ≤ 1.6 mg/dL and creatinine clearance ≥ 60 mL/min
  • AST and ALT ≤ 5 times the upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective method of contraception
  • No contraindication for MRI including, but not limited to, any of the following:

    • Cardiac pacemaker
    • Implanted cardiac defibrillator
    • Aneurysm clips
    • Carotid artery vascular clamp
    • Neurostimulator
    • Insulin or infusion pump, or implanted drug infusion device
    • Claustrophobia
    • Weight > 350 lbs
  • Able to take medications orally
  • No uncontrolled bacterial, viral, or fungal infection

PRIOR CONCURRENT THERAPY:

  • Prior therapy with deferoxamine allowed provided it was completed ≥ 12 months ago
  • More than 4 weeks since prior and no concurrent systemic investigational drug
  • More 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
  • No 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
  • Not on dialysis or status post-renal transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602446

Locations
United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o     612-624-2620        
United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center     800-641-2422        
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Linda J. Burns, MD Masonic Cancer Center, University of Minnesota
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Masonic Cancer Center at University of Minnesota ( Linda Jean Burns )
Study ID Numbers: CDR0000584690, UMN-2007LS065, UMN-MT2007-11R, NOVARTIS-CICL670AUS12
Study First Received: January 24, 2008
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00602446  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
iron overload
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
myelodysplastic/myeloproliferative disease, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Urogenital Neoplasms
Iron Metabolism Disorders
Lymphoma, large-cell, immunoblastic
Preleukemia
Hemorrhagic Disorders
Neoplasm Metastasis
Neuroepithelioma
Endocrine Gland Neoplasms
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Metabolic Diseases
Deferasirox
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Genital Neoplasms, Female
Acute myelogenous leukemia
Breast Neoplasms
Testicular Neoplasms
Leukemia, Myeloid
Myelodysplastic myeloproliferative disease
Leukemia, Myeloid, Accelerated Phase
B-cell lymphomas
Iron Overload

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Disease
Pregnancy Complications, Neoplastic
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Neoplasms, Nerve Tissue
Iron Chelating Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Pathologic Processes
Syndrome
Cardiovascular Diseases
Chelating Agents
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 14, 2009