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A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Deferasirox in Patients With Myelodysplastic Syndromes (Low/Int-1 Risk) and Transfusional Iron Overload


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndromes

Thank you

Trial Information

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Deferasirox in Patients With Myelodysplastic Syndromes (Low/Int-1 Risk) and Transfusional Iron Overload


Inclusion 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

Exclusion Criteria:

- 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 < 55% by ECHO

- History of hospitalization for Congestive Heart Failure

- Systemic disease that would prevent study treatment (uncontrolled hypertension,
cardiovascular renal, hepatic 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

To compare deferasirox to placebo with regard to event-free survival (a composite primary endpoint including death and non-fatal events related to cardiac and liver function) in low and int-1 risk MDS patient with transfusional iron overload.

Outcome Time Frame:

1 year - 5 years

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CICL670A2302

NCT ID:

NCT00940602

Start Date:

March 2010

Completion Date:

January 2018

Related Keywords:

  • Myelodysplastic Syndromes
  • TELESTO
  • MDS Study
  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes (low-int-1 risk)
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Hendrick Cancer Center Abilene, Texas  79601-2316
Texas Cancer Center - Abilene Abilene, Texas  79606
Puget Sound Cancer Center Edmonds, Washington  98026
University of Chicago Medical Center Dept. of U. of Chicago Hosp(3) Chicago, Illinois  60546
Hematology/Oncology Consultants Inc. West Worthington, Ohio  43235
US Oncology Central Monitoring Dallas, Texas  75246
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio San Antonio, Texas  78229
Rocky Mountain Cancer Centers RMCC - Denver-Midtown Greenwood Village, Colorado  
Tyler Cancer Center Dept.ofTylerCancerCtr. Tyler, Texas  75702
Dean Health System Madison, Wisconsin  53717
Arizona Oncology Associates Phoenix Phoenix, Arizona  
Hematology Oncology Services of Arkansas HOSA 2 Little Rock, Arkansas  72205
Pacific Cancer Medical Center, Inc. PAC Center Anaheim, California  92801
Tower Cancer Research Tower Oncology Beverly Hills, California  90211
City of Hope National Medical Center City of Hope Medical Center Duarte, California  91010
Long Beach VA Medical Center Dept. of Long Beach VA Med.Ctr Long Beach, California  90822
USC/Kenneth Norris Comprehensive Cancer Center USC Los Angeles, California  90033
Comprehensive Cancer Center CCC - Palm Spriings Palm Springs, California  92262
Hartford Hospital Cancer Clinic Office Hartford, Connecticut  06102
Sylvester Comprehensive Cancer Center Sylvester Cancer Miami, Florida  33136
Florida Medical Clinic PA Dept.ofFloridaMedicalClinic Zephyrhills, Florida  33542
Northeast Georgia Cancer Care Dept of NE Georgia Cancer (2) Athens, Georgia  30607
Mountain States Tumor Institute Mountain States Boise, Idaho  83712
Rush University Medical Center Div.ofHematology&Oncology (2) Chicago, Illinois  60612
North Shore University Health System NSU Evanston, Illinois  60201
North Shore University Health System North Shore Evanston, Illinois  60201
University of Iowa Hospitals & Clinics Univ Iowa Iowa City, Iowa  52242
Siouxland Hematology-Oncology Associates LLP SHO Sioux City, Iowa  51101
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3) New Orleans, Louisiana  70115
Henry Ford Hospital Henry Ford Detroit, Michigan  48202
Essentia Health Duluth Clinic Duluth Clinic Duluth, Minnesota  55805
Veterans Medical Center -Minneapolis MVMC Minneapolis, Minnesota  55417
Missouri Cancer Associates Dept.ofMissouriCancerAssoc. Columbia, Missouri  65201
Midwest Cancer Care Physicians MMCC Kansas City, Missouri  64131
Washington University School Of Medicine-Siteman Cancer Ctr WUSCM St. Louis, Missouri  63110
VA Southern Nevada Healthcare System VASNHS Las Vegas, Nevada  89106
Comprehensive Cancer Centers of Nevada CCC Nevada US Onc Las Vegas, Nevada  89109
Southern Nevada Cancer Research Foundation Dept.of So. NV CancerRes.Fdn Las Vegas, Nevada  89106
East Orange VA Medical Center Dept.ofHematology/Oncology(2) East Orange, New Jersey  07018-1095
Hackensack University Medical Center Dept.of HackensackUniv.MedCtr. Hackensack, New Jersey  07601
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (3) Morristown, New Jersey  07962
UMDNJ-Robert Wood Johnson Clinical Research Center UMDNJ-Robert Wood Johnson Med New Brunswick, New Jersey  08903
Overlook Hospital - Carol G Simon Cancer Center Carol G Simon Summit, New Jersey  07901
Montefiore Medical Center Medical Oncology Bronx, New York  10467
St. Vincent's Comprehensive Cancer Center St Vincents CCC New York, New York  10011
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC Troy, New York  12180
Wake Forest University Baptist Medical Center Dept. of WFUHS (2) Winston-Salem, North Carolina  27157
University of Oklahoma Health Sciences Center Univ OK HSC Oklahoma City, Oklahoma  73104
Western Pennsylvania Hospital The Western Pennsylvania Hospi Pittsburgh, Pennsylvania  15224
The West Clinic Dept. of the West Clinic Memphis, Tennessee  38120
Cancer Center of the High Plains Amarillo, Texas  79106
South Texas Institute of Cancer South Texas Corpus Christi, Texas  78405
Texas Oncology, P.A. TX Onc Dallas, Texas  75251
University of Texas Southwestern Medical Center UTSW 6 Dallas, Texas  75390-8527
Texas Oncology, P.A. Presbyterian Hospital (2) Dallas, Texas  75246
ClinRx Research ClinRx Rearch (2) Denton, Texas  76210
Texas Oncology, P.A. Texas Oncology Lewisville Fort Worth, Texas  76104
Baylor College of Medicine Baylor College of Medicine (2) Houston, Texas  77030
The Baylor College of Medicine/The Methodist Hospital The Methodist Hospital Houston, Texas  77030
MD Anderson Cancer Center/University of Texas Dept of MD Anderson (16) Houston, Texas  77030-4009
Cancer Care Centers of South Texas / HOAST CCC of So.TX- MedicalCenter(2) San Antonio, Texas  78229
Veterans Hospital VA Med Ctr White River Junction, Vermont  05009
Delta Oncology Associates Portsmouth, Virginia  23704
Columbia Basin Hematology CBHO Kennewick, Washington  99336
Yakima Valley Memorial Hospital North Star Lodge Yakima, Washington  98902
Charleston Area Medical Center David Lee Cancer Center Charleston, West Virginia  25304
University of California at Los Angeles UCLA Los Angeles, California  90095
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
Georgia Regents University SC Augusta, Georgia  30912
Cedar Valley Medical Specialsts Dept of Oncology Waterloo, Iowa  50701
Kansas City Cancer Center KCCC - South Overland Park, Kansas  66210
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Willis-Knighton Cancer Center New Orleans, Louisiana  70115
University of Maryland Medical Center SC-2 Baltimore, Maryland  21201
Cancer and Hematology Centers of Western Michigan, PC Dept of Oncology Grand Rapids, Michigan  49546
Mercy Medical Research Institute SC Manchester, Missouri  63021
Glacier View Research Institute - Cancer SC Kalispell, Montana  59901
Mid Dakota Clinic, P.C. Dept of Oncology Bismark, North Dakota  58501