Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study
TELESTO
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
2 other identifiers
interventional
225
16 countries
71
Brief Summary
This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was conducted in 17 countries, started in 2010 and ended in 2018.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2010
Longer than P75 for phase_2
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2009
CompletedFirst Posted
Study publicly available on registry
July 16, 2009
CompletedStudy Start
First participant enrolled
March 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2018
CompletedResults Posted
Study results publicly available
November 23, 2020
CompletedNovember 23, 2020
October 1, 2020
7.9 years
July 15, 2009
February 25, 2019
October 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-free Survival
Event-free survival was defined as the time from the date of randomization to the date of the first documented non-fatal event (worsening cardiac function, hospitalization for congestive heart failure, liver function impairment, liver cirrhosis, transformation to AML, as defined in the protocol), or death, whichever occurred first. Participants who did not experience a non-fatal event as of the time of data cut-off (end of study), as well as participants who did not experience a non-fatal event and stopped study participation before the data cut-off, were censored as specified in the protocol.
Day 1 to end of treatment period, approx. 7 years
Secondary Outcomes (14)
Percentage of Participants With Hematologic Improvement (HI) in Terms of Erythroid Response
Day 1 to end of treatment period, approx. 7 years
Overall Survival
Day 1 to end of treatment period, approx. 7.4 years
Percentage of Participants With Newly Occurring Hypothyroidism Compared to Baseline
Day 1 to end of treatment period, approx. 7 years
Percentage of Participants With Worsening Glucose Metabolism Compared to Baseline
Day 1 to end of treatment period, approx. 7 years
Time to Disease Progression
Day 1 to end of treatment period, approx. 7 years
- +9 more secondary outcomes
Study Arms (2)
Deferasirox
EXPERIMENTAL10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range.
Placebo
PLACEBO COMPARATOR10 mg/kg/day (once daily) for the first 2 weeks of treatment, followed by 20 mg/kg/day (once daily) from Week 2 to End of Treatment. After 3 months of treatment at 20 mg/kg/day, the dose was allowed to be adjusted by 5 or 10 mg/kg/day up to 40 mg/kg/day based on serum ferritin responses. When a target serum ferritin level was reached (usually between 500 and 1000 µg/L), the dose could be reduced by 50% to maintain the serum ferritin within the target range.
Interventions
Deferasirox provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use
Inactive ingredients used as a placebo comparator, provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use
Eligibility Criteria
You may qualify if:
- Weigh between 35-135 kilograms
- Low or int-1 risk MDS
- Ferritin \>1000 micrograms/liter at screening
- History of transfusion of 15 to 75 Packed Red Blood Cells (PRBC) units
- Anticipated to be transfused with at least 8 units of PRBCs annually during the study
- Women of child-bearing potential using effective methods of contraception during dosing of study treatment
You may not qualify if:
- More than 6 months of cumulative ICT (such as daily deferasirox (Exjade®) or deferiprone or 5×/week deferoxamine)
- More than 3 years since patient began receiving regular transfusions (2 units per 8 weeks or 4 units received in a 3 month period)
- Significant proteinuria
- History of hospitalization for congestive heart failure; other heart conditions as specified in the protocol
- Systemic diseases which would prevent study treatment
- Hepatitis B; Hepatitis C; HIV
- Liver cirrhosis
- Pregnant, or breast-feeding patients, or patients of child-bearing potential not employing an effective method of birth control
- History of drug or alcohol abuse within the 12 months prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Pacific Cancer Medical Center, Inc. PAC Center
Anaheim, California, 92801, United States
Rocky Mountain Cancer Centers RMCC
Greenwood Village, Colorado, United States
Willis-Knighton Cancer Center Dept of Onc
Shreveport, Louisiana, 71103, United States
Henry Ford Hospital Henry Ford
Detroit, Michigan, 48202, United States
Midwest Cancer Care Physicians MMCC
Kansas City, Missouri, 64131, United States
Mercy Medical Research Institute SC
Manchester, Missouri, 63021, United States
Glacier View Research Institute - Cancer SC
Kalispell, Montana, 59901, United States
Hackensack University Medical Center Department of Research
Hackensack, New Jersey, 07601, United States
University of Texas MD Anderson Cancer Center Dept of MD Anderson (16)
Houston, Texas, 77030, United States
Cancer Care Centers of South Texas HOAST CCC of So.TX- MedicalCenter(2)
San Antonio, Texas, 78229, United States
Swedish Cancer Institute Ballard Campus
Seattle, Washington, 98107, United States
Novartis Investigative Site
Herston, Queensland, 4029, Australia
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Plovdiv, 4002, Bulgaria
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Sofia, 1407, Bulgaria
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Varna, 9010, Bulgaria
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Edmonton, Alberta, T6G 2B7, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Brampton, Ontario, L6R 3J7, Canada
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St. Catharines, Ontario, L2S 0A9, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Guangzhou, Guangdong, 51000, China
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Wuhan, Hubei, 430022, China
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Nanjing, Jiangsu, 210029, China
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Suzhou, Jiangsu, 215006, China
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Shanghai, Shanghai Municipality, 200437, China
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Tianjin, Tianjin Municipality, 300020, China
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Hangzhou, Zhejiang, 310003, China
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Beijing, 100044, China
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Jinan, 250012, China
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Shanghai, 200025, China
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Shanghai, 200233, China
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Copenhagen, DK-2100, Denmark
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Herlev, DK 2730, Denmark
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Athens, GR, 115 27, Greece
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Ioannina, GR, 455 00, Greece
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Athens, 115 27, Greece
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PĂ¡trai, 265 00, Greece
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Shatin, New Territories, Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Bologna, BO, 40138, Italy
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Cagliari, CA, 09126, Italy
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San Giovanni Rotondo, FG, 71013, Italy
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Florence, FI, 50134, Italy
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Messina, ME, 98125, Italy
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Pescara, PE, 65124, Italy
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Reggio Calabria, RC, 89124, Italy
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Orbassano, TO, 10043, Italy
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Kuching, Sarawak, 93586, Malaysia
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Kuala Selangor, 68000, Malaysia
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Mexico City, Mexico City, 02990, Mexico
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Mexico City, Mexico City, 06726, Mexico
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Auckland, 1309, New Zealand
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Auckland, New Zealand
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Christchurch, 8001, New Zealand
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Moscow, 125167, Russia
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Rostov-on-Don, 344022, Russia
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Basel, 4031, Switzerland
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Zurich, 8091, Switzerland
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Khon Kaen, THA, 40002, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Glasgow, Scotland, G12 0YN, United Kingdom
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Birmingham, B15 2TH, United Kingdom
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Bournemouth, BH7 7DW, United Kingdom
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Cardiff, CF14 4XW, United Kingdom
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Exeter, EX2 5DW, United Kingdom
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Kent, DA2 8DA, United Kingdom
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Macclesfield, SK10 3BL, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Oxford, OX3 7LJ, United Kingdom
Related Publications (1)
Angelucci E, Li J, Greenberg P, Wu D, Hou M, Montano Figueroa EH, Rodriguez MG, Dong X, Ghosh J, Izquierdo M, Garcia-Manero G; TELESTO Study Investigators. Iron Chelation in Transfusion-Dependent Patients With Low- to Intermediate-1-Risk Myelodysplastic Syndromes: A Randomized Trial. Ann Intern Med. 2020 Apr 21;172(8):513-522. doi: 10.7326/M19-0916. Epub 2020 Mar 24.
PMID: 32203980DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Patients, investigator staff, persons performing the assessments, and data analysts remained blind to the identity of the study treatment from the time of randomization until database lock.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2009
First Posted
July 16, 2009
Study Start
March 22, 2010
Primary Completion
February 27, 2018
Study Completion
February 27, 2018
Last Updated
November 23, 2020
Results First Posted
November 23, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.