Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study (TELESTO)
This study is currently recruiting participants.
Verified April 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
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
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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:
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
Show 182 Study Locations
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Show 182 Study LocationsSponsors 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