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. 2014 Oct 28;2014(10):CD007461. doi: 10.1002/14651858.CD007461.pub3

TELESTO 2009.

Trial name or title MDS event free survival with iron chelation therapy study (TELESTO)
Methods A multi‐centre, randomised, double‐blind, placebo‐controlled clinical trial of deferasirox in patients with MDS (low/int‐1 risk) and transfusional iron overload
Participants Inclusion criteria:
  • Males or females ≥ 18 years of age

  • MDS low and int‐1 risk as determined by IPSS score and confirmed by bone marrow examination within 12 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

  • Patients must weigh between 35kg to 135 kg


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 (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 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 enrolment.


Other protocol‐defined inclusion/exclusion criteria may apply.
Interventions Experimental: Deferasirox
Placebo: Placebo
Outcomes Primary outcome measures:
  • Event‐free survival (a composite primary endpoint including death and non‐fatal events related to cardiac and liver function) (time frame: 1 year to 5 years)


Secondary outcome measures:
  • Hematologic improvement in terms of erythroid responses during treatment

  • Overall survival

  • Proportion of patients with hypothyroidism

  • Proportion of patients with worsening of glucose metabolism

  • Disease progression

  • Time to first occurrence of serum ferritin > 2 times the baseline value

  • Time to at least a 10% increase from baseline in LVISD

  • Time to at least a 10% increase from baseline in LVISD

  • Infections

  • Proportion of patients with significant renal dysfunction

  • Proportion of patients with severe neutropenia or thrombocytopenia

  • Proportion of patients with major gastrointestinal bleeding

  • Time to study drug discontinuation due to an AE or laboratory abnormality

Starting date Study start date: March 2010
Estimated primary completion date: February 2018 (final data collection date for primary measure)
Contact information Novartis Pharmaceuticals
Notes
  • Planned sample size: 210

  • ClinicalTrials.gov Identifier: NCT00940602

  • Study ID Number: CILC670A2302

  • Registry entry last updated on 05/02/2014

Information in tables given according to www.clinicaltrials.gov. We searched ClinicalTrials.gov on 16 April 2014.