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Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study (TELESTO)

This study is currently recruiting participants.
Verified April 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00940602
First received: July 15, 2009
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Myelodysplastic Syndromes
 Drug: Deferasirox
Drug: Deferasirox placebo
 Phase 3

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

Resource links provided by NLM:

Drug Information available for: Deferasirox
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year - 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare overall survival Measure: Survival to date of death [ Time Frame: 1 year-5 years ] [ Designated as safety issue: No ]
  • To evaluate the change in endocrine function: thyroid Measure: TSH, Free T4 [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • To evaluate the change in glucose metabolism: Measure: Glucose Tolerance Testing [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • To evaluate the change in MDS progression [ Time Frame: From date of Randomization Up to 5 years ] [ Designated as safety issue: No ]
  • To evaluate the change in hematological function expressed in frequency/total amount of blood transfusions during trial Measure: milliliters of blood [ Time Frame: From date of Randomization Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: March 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deferasirox, iron chelator Drug: Deferasirox
Placebo Comparator: Placebo Drug: Deferasirox placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940602

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 182 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00940602     History of Changes
Other Study ID Numbers: CICL670A2302, 2009-012418-38
Study First Received: July 15, 2009
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
TELESTO
MDS Study
Myelodysplastic Syndromes
Myelodysplastic Syndromes (low-int-1 risk)

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
 Deferasirox
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013