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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00602446 |
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 |
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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 |
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 |
Estimated Enrollment: | 10 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
Ineligible for phlebotomy (hemoglobin < 11 g/dL, poor intravenous access, or unable to undergo phlebotomy every 4 weeks)
PATIENT CHARACTERISTICS:
No contraindication for MRI including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
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 |
Principal Investigator: | Linda J. Burns, MD | Masonic Cancer Center, University of Minnesota |
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 |
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 |
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 |
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 |