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9L-11-2: A Multi-Center, Randomized, Double-Blind, Placebocontrolled Clinical Trial of Deferasirox in Patients with Myelodysplastic Syndromes (Low/Int-1 Risk) and Transfusional Iron Overload (TELESTO) CICL670A2302

Description

The primary purpose of this study is to prospectively assess the efficacy and safety of iron chelation therapy with deferasirox compared to placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion Criteria

  • Males or females ≥ 18 years of age
  • Patients must weigh between 35-135 kg MDS low -int-1 risk as determined by IPSS score and confirmed by bone marrow examination within 6 months prior to study entry
  • Ferritin> 1000 mcg/L at screening
  • History of 15 to 75 PRBC transfusions
  • Anticipated to be transfused at least 8 times annually during the study

  • More than 6 months of cumulative iron-chelation therapy (such as daily deferasirox (Exjade) or deferiprone or 5x/week deferosamine). intermittent deferoxamine doses in association with blood transfusions are not exclusionary regardless of duration of such treatment. -
  • More than 3 years since patient began receiving regular transfusions (2 units per 8 weeks or 4 units received in a 3 month period).
  • Creatinine clearance < 40 ml/min
  • Serum creatinine >1.5x ULN at screening
  • Significant proteinuria: urinary protein/creatinine ratio >0.5 mg/mg in a non first void urine sample
  • ECOG performance status > 2
  • Left ventricular ejection fraction < 50% by ECHO
  • History of hospitalization for Congestive Heart Failure
  • Systemic disease that would prevent study treatment (uncontrolled hypertension, cardiovascular renal, hepatic (including Child-Pugh Class B and C) or metabolic disease)
  • Hepatitis B or C (HBsAg in the absences or HBsAB or HCV Ab positive with HCV RNA positive)
  • History of HIV positivity by (ELISA or Western blot)
  • Treatment with systemic investigational drug within 4 weeks or topical investigational drug within 7 days of study start
  • ALT or AST > 3.5 x ULN at screening
  • Total bilirubin > 1.5 x ULN at screening
  • Diagnosis of liver cirrhosis
  • Patient participating in another clinical trial or receiving an investigational drug
  • History of another malignancy within the past five years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ
  • History of non-compliance with medical regimen, or patients potentially unreliable and/or not cooperative
  • Presence of surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
  • Pregnant or intending to become pregnant or breast-feeding patents
  • History of drug or alcohol abuse within the 12 months prior to enrollment.
  • Other protocol-defined inclusion/exclusion criteria may apply

Sites

  • California

    • USC/Kenneth Norris Comprehensive Cancer Center USC, Los Angeles, California, 90033
    • Tower Cancer Research Tower Oncology, Beverly Hills, California, 90211
    • City of Hope Medical Center City of Hope Medical Center, Duarte, California, 91010
    • University of California at Los Angeles UCLA, Los Angeles, California, 90095
    • Long Beach VA Medical Center Dept. of Long Beach VA Med.Ctr, Long Beach, California, 90822
    • Long Beach VA Medical Center Dept. of Long Beach VA Med.Ctr, Long Beach, California, 90822
    • Pacific Cancer Medical Center, Inc. PAC Center, Anaheim, California, 92801
    • Pacific Cancer Medical Center, Inc. PAC Center, Anaheim, California, 92801
    • Comprehensive Cancer Center CCC - Palm Spriings, Palm Springs, California, 92262
    • University of California at San Diego, Moores Cancer Ctr Dept. of MooresCancerCenter(3), San Diego, California, 92103
    • Stanford University Medical Center Division of Hematology 2, Stanford, California, 94304
  • Nevada

    • Comprehensive Cancer Centers of Nevada CCC Nevada US Onc, Las Vegas, Nevada, 89109
    • VA Southern Nevada Healthcare System VASNHS, Las Vegas, Nevada, 89106
    • Southern Nevada Cancer Research Foundation Dept.of So. NV CancerRes.Fdn, Las Vegas, Nevada, 89106
  • Idaho

    • Mountain States Tumor Institute Mountain States, Boise, Idaho, 83712
  • Washington

    • Columbia Basin Hematology CBHO, Kennewick, Washington, 99336
    • Columbia Basin Hematology & Oncology CBHO, Kennewick, Washington, 99336
    • Yakima Valley Memorial Hospital North Star Lodge Cancer Center, Yakima, Washington, 98902
    • Swedish Cancer Institute, Seattle, Washington, 98107
  • Texas

    • Cancer Center of the High Plains, Amarillo, Texas, 79106
    • Texas Cancer Center - Abilene, Abilene, Texas, 79606
    • Hendrick Cancer Center, Abilene, Texas, 79601
    • Cancer Care Centers of South Texas / HOAST CCC of So.TX- MedicalCenter(2), San Antonio, Texas, 78229
    • Cancer Care Centers of South Texas / HOAST CCC of So.TX- MedicalCenter(2), San Antonio, Texas, 78229
    • Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio, San Antonio, Texas, 78229
    • Texas Oncology, P.A. Texas Oncology Lewisville, Fort Worth, Texas, 76104
    • ClinRx Research ClinRx Rearch (2), Denton, Texas, 76210
    • Texas Oncology, P.A. TX Onc, Dallas, Texas, 75251
    • Texas Oncology TX Onc, Dallas, Texas, 75251
    • Texas Oncology, P.A. Presbyterian Hospital (2), Dallas, Texas, 75246
    • Texas Oncology Presbyterian Hospital (2), Dallas, Texas, 75246
    • US Oncology Central Monitoring, Dallas, Texas, 75246
    • South Texas Institute of Cancer South Texas, Corpus Christi, Texas, 78405
    • Tyler Cancer Center Dept.ofTylerCancerCtr., Tyler, Texas, 75702
    • The Methodist Hospital The Methodist Hospital, Houston, Texas, 77030
    • Baylor College of Medicine Baylor College of Medicine (2), Houston, Texas, 77030
  • Montana

    • Glacier View Research Institute - Cancer SC, Kalispell, Montana, 59901
    • Glacier View Research Institute - Cancer SC, Kalispell, Montana, 59901
  • Oklahoma

    • University of Oklahoma Health Sciences Center Univ OK HSC, Oklahoma City, Oklahoma, 73104
  • Iowa

    • Siouxland Hematology-Oncology Associates LLP SHO, Sioux City, Iowa, 51101
    • Siouxland Hematology-Oncology Associates LLP SHO, Sioux City, Iowa, 51101
    • Cedar Valley Medical Specialsts Dept of Oncology, Waterloo, Iowa, 50701
    • University of Iowa Hospitals & Clinics U of Iowa Hosp. & Clinics, Iowa City, Iowa, 52242
  • Kansas

    • Kansas City Cancer Center KCCC - South, Overland Park, Kansas, 66210
    • Kansas City Cancer Center KCCC - South, Overland Park, Kansas, 66210
  • Missouri

    • Midwest Cancer Care Physicians MMCC, Kansas City, Missouri, 64131
    • Mercy Medical Research Institute SC, Manchester, Missouri, 63021
    • Mercy Medical Research Institute SC, Manchester, Missouri, 63021
    • Washington University School of Medicine WUSCM, St. Louis, Missouri, 63110
  • Louisiana

    • Willis-Knighton Cancer Center Dept of Onc, Shreveport, Louisiana, 71103
    • LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3), New Orleans, Louisiana, 70115
  • Arkansas

    • Hematology Oncology Services of Arkansas HOSA 2, Little Rock, Arkansas, 72205
  • Minnesota

    • Veterans Medical Center -Minneapolis MVMC, Minneapolis, Minnesota, 55417
    • Essentia Health Duluth Clinic Duluth Clinic, Duluth, Minnesota, 55805
  • Tennessee

    • The West Clinic Dept. of the West Clinic, Memphis, Tennessee, 38120
  • Wisconsin

    • Dean Health System, Madison, Wisconsin, 53717
  • Illinois

    • University of Chicago Medical Center Dept. of U. of Chicago Hosp(3), Chicago, Illinois, 60546
    • Rush University Medical Center Div.ofHematology&Oncology (2), Chicago, Illinois, 60612
    • North Shore University Health System North Shore, Evanston, Illinois, 60201
    • North Shore University Health System NSU, Evanston, Illinois, 60201
  • Michigan

    • Cancer and Hematology Centers of West Michigan, PC Dept of Oncology, Grand Rapids, Michigan, 49546
  • Sarawak

    • Novartis Investigative Site, Kuching, Sarawak, 93586
  • RC

    • Novartis Investigative Site, Reggio Calabria, RC, 89124
  • CT

    • Novartis Investigative Site, Catania, CT, 95124
  • Italy

    • Novartis Investigative Site, Napoli, 80136
  • ME

    • Novartis Investigative Site, Messina, ME, 98125
  • FI

    • Novartis Investigative Site, Firenze, FI, 50134
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