Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy.
NCT ID: NCT02038036
Last Updated: 2021-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
149 participants
INTERVENTIONAL
2014-03-25
2020-04-07
Brief Summary
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Detailed Description
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The study comprised of the following periods:
Screening Period (up to 5 weeks: Day -35 to Day -1): Screening evaluations were performed at one or more clinic visits, and reviewed to determine eligibility before the patient was randomized in the study.
Core Treatment Period (Day 1 to Week 80):
Patients were randomized in 1:1 ratio to either treatment group (ruxolitinib or BAT) and were to be treated with their randomized treatment.
Crossover Treatment Period (Week 28 or after) for BAT patients only:
Patients randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib. Patients crossing over on or after Week 28 had to complete all assessments for the End of Treatment (EoT) visit of the Core Treatment Period followed by the assessments in Cross-over visit evaluation schedule.
Extended Treatment Period (Week 80 to Week 260):
Patients receiving ruxolitinib at Week 80 (including patients who have crossed over from BAT) were eligible to continue up to Week 260 in the Extended Treatment Period. Patients continued the ruxolitinib dose that they received at Week 80. Patients who received BAT at Week 80 were not eligible to enter the Extended Treatment Period and had to have the EoT visit at Week 80 and an End of study (EoS) visit 30 days after the EoT visit.
Follow-up Period:
Patients were followed for safety during 30 days after the last dose of study drug and EoS visit assessments were performed post 30 days after the last dose of study drug. Patients who completed EoT (Week 80 for patients who received BAT, Week 260 for patients who received ruxolitinib or from the time of premature discontinuation) were to be followed-up for every 3 months for survival till the end of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ruxolitinib
Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.
Ruxolitinib
Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.
Best Available Therapy (BAT)
Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.
Best Available Therapy
Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.
Interventions
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Best Available Therapy
Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.
Ruxolitinib
Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Herston, Queensland, Australia
Novartis Investigative Site
Antwerp, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Bayonne, Bayonne Cedex, France
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Bordeaux, , France
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Brest, , France
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Lille, , France
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Nice, , France
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Paris, , France
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Toulouse, , France
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Mannheim, Baden-Wurttemberg, Germany
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Augsburg, , Germany
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Dresden, , Germany
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Jena, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Minden, , Germany
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Ulm, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Kaposvár, , Hungary
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Mumbai, Maharashtra, India
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Vellore, Tamil Nadu, India
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Nahariya, , Israel
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Netanya, , Israel
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Tel Aviv, , Israel
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Bologna, BO, Italy
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Florence, FI, Italy
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Rome, Lazio, Italy
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Milan, MI, Italy
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Pavia, PV, Italy
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Torino, TO, Italy
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Varese, VA, Italy
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Seoul, , South Korea
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Seoul, , South Korea
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Málaga, Andalusia, Spain
Novartis Investigative Site
Salamanca, Castille and León, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
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A Coruña, Galicia, Spain
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Las Palmas de Gran Canaria, Las Palmas de G.C, Spain
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Pamplona, Navarre, Spain
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Alicante, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Talas / Kayseri, , Turkey (Türkiye)
Countries
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References
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Passamonti F, Palandri F, Saydam G, Callum J, Devos T, Guglielmelli P, Vannucchi AM, Zor E, Zuurman M, Gilotti G, Zhang Y, Griesshammer M. Ruxolitinib versus best available therapy in inadequately controlled polycythaemia vera without splenomegaly (RESPONSE-2): 5-year follow up of a randomised, phase 3b study. Lancet Haematol. 2022 Jul;9(7):e480-e492. doi: 10.1016/S2352-3026(22)00102-8. Epub 2022 May 18.
Kiladjian JJ, Guglielmelli P, Griesshammer M, Saydam G, Masszi T, Durrant S, Passamonti F, Jones M, Zhen H, Li J, Gadbaw B, Perez Ronco J, Khan M, Verstovsek S. Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies. Ann Hematol. 2018 Apr;97(4):617-627. doi: 10.1007/s00277-017-3225-1. Epub 2018 Feb 2.
Passamonti F, Griesshammer M, Palandri F, Egyed M, Benevolo G, Devos T, Callum J, Vannucchi AM, Sivgin S, Bensasson C, Khan M, Mounedji N, Saydam G. Ruxolitinib for the treatment of inadequately controlled polycythaemia vera without splenomegaly (RESPONSE-2): a randomised, open-label, phase 3b study. Lancet Oncol. 2017 Jan;18(1):88-99. doi: 10.1016/S1470-2045(16)30558-7. Epub 2016 Dec 2.
Other Identifiers
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CINC424B2401
Identifier Type: -
Identifier Source: org_study_id
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