The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV
NCT ID: NCT03003325
Last Updated: 2024-09-19
Study Results
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Basic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2017-02-02
2023-03-31
Brief Summary
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Detailed Description
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Eligible patients are randomized to be treated with the best available therapy (recommended for this risk class, standard arm) based on phlebotomy including administration of low-dose (100 mg/daily) of acetylsalicylic acid (ASA, when there are not contraindications) OR Pegylated Proline-Interferon alpha-2b (AOP2014) every 2 weeks in addition to the recommended available regimen (experimental arm), for up to 12 months. The allocation of patients to study arms is 1:1 and stratification at randomization will be performed according to age category (\< 50 years old or \> 50 years old) and time from diagnosis (naϊve or non-naϊve). Naive patients are defined as new cases coming to observation, diagnosed for the first time just before study entry and never treated; non-naive patients are old cases (diagnosis not older than 3 years before study entry) undergoing therapy with phlebotomy and/or low doses of ASA.
Primary endpoint (PEp) is defined by the proportion (%) of patients who maintain the median value of hematocrit (HCT) below 45% during 12 months of treatment in each arm, without progression of disease and no need of any extra-protocol cytoreductive drug (responder patients).
Secondary endpoints include evaluation of hematological and molecular response, histological remission and safety profile of the protocol therapy.
Before randomization all patients undergo phlebotomies in order to reach an HCT below 45%.
After randomization, according to current common clinical practice the regimen of phlebotomies must be selected accordingly to maintain the recommended level of HCT\< 45%. Once normalization of the HCT has been achieved, blood counts at regular intervals (every 4 weeks) will establish the frequency of future phlebotomies. Sufficient blood is recommended to be removed in order maintain the hematocrit below 45%. Supplemental iron therapy should not be administered.
All patients receive low-dose of ASA (100 mg/daily) as recommended by the current guidelines for low-risk subjects with PV.
Patients allocated in the experimental group receive in addition a pre-filled auto-injection pen for the subcutaneous auto-administration (into the abdominal skin or the thigh) of 100 µg of Pegylated Proline-Interferon alpha-2b (AOP2014) once every 14 days.
Patient visits are scheduled every month (4 weeks) for 12 months to assess and perform a reliable calculation of the primary end-point (% of patients with median HCT levels \<45%).
At each monthly visit a pre-filled auto-injection pen is delivered to the patients who have been randomized in the experimental arm.
Assuming an expected drop-out rate of 12%, a total sample size of 150 patients (75 randomized in each group) will be randomized to reject the null hypothesis that the proportion of patients achieving the primary endpoint is 50% in favor of the alternative hypothesis that this proportion is 75% when AOP2014 is added to the phlebotomy based- therapy, with a power of 80% and an alpha error of 0.05 (two-tailed).
Two interim-analysis are planned when 50 and 100 of randomized patients have completed the 12 months study, respectively, in order to evaluate and supervise both safety and primary endpoint. The Lan and DeMets (1983) spending function with O'Brien-Fleming type boundaries will be employed to preserve the overall two-sided type I error rate for effectiveness at the 0.05 level, regardless of the timing of the analysis.
The results of the second interim analysis carried out at in April 2020 indicated a significant higher efficacy of the experimental arm than standard arm. The composite primary end-point was reached in 84% in patients of Ropeginterferon arm vs. 60% in standard arm (p=0.008, Odds Ratio=3.5, 95% CI: 1.3-10.4). This result, according to the statistical evaluation for futility and efficacy, reveals that , the null hypothesis is already been proven with first 100 patients randomized and cannot change in the future when 150 patients will enter the study. Therefore the data safety monitoring board and the steering committee agree that the accrual of new patients can be interrupted with 127 patients included.
The primary endpoint assessment is performed after the completion of the first 12 months of therapy for all subjects enrolled ('core study').
A period of 12 months is expected for completion of the enrolment / randomization phase. The 'core study' itself will take 12 months of treatment per patient.
Based on results from the 'core study' the extension phase will continue as follows:
1. After 12 month patients who meet the primary endpoint following either conventional or experimental therapy will enter the extension phase and remain on their current regimen.
2. non-responders, not meeting the primary endpoint after 12 months of conventional therapy will be switched to the experimental treatment.
3. non-responder, not meeting the primary endpoint after 12 months of experimental therapy will be switched to conventional treatment.
This extension phase will last for another 12 months from the Last Visit Last Patient included (LVLP) into the core study (matching cases 1 and 2 as defined above). Based on this, the overall length of the study is expected to cover a period of 36 months from the First Patient Included (FPI).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phlebotomies + ASA
Conventional treatment based on phlebotomies and low dose (100 mg) of acetylsalicylic acid (ASA)
Phlebotomies
According to current common clinical practice the regimen must be selected accordingly to maintain the recommended level of HCT\< 45%. Once normalization of the hematocrit has been achieved, blood counts at regular intervals (every 4 weeks) will establish the frequency of future phlebotomies. Sufficient blood should be removed to maintain the hematocrit below 45%.
ASA
100 mg/daily of ASA is recommended (when there are not contraindications) according with current guidelines for this risk class of patients
Phlebotomies + ASA + AOP2014
Conventional treatment based on phlebotomies, low dose (100 mg) of acetylsalicylic acid (ASA) plus the addition of 100 µg of Pegylated Proline-Interferon alpha-2b (AOP2014) once every 14 days (subcutaneously).
AOP2014
AOP2014 will be supplied to the patients as pre-filled auto-injection pens, containing 250 µg of active drug (0.5 ml solution for injection). One pen may be used twice within a time period of 4 weeks. Hence investigators will provide one prefilled pen at every monthly visit. AOP2014 will be self-injected subcutaneously by patients once every 14 days at the single doses of 100 µg (0.2 ml).
Phlebotomies
According to current common clinical practice the regimen must be selected accordingly to maintain the recommended level of HCT\< 45%. Once normalization of the hematocrit has been achieved, blood counts at regular intervals (every 4 weeks) will establish the frequency of future phlebotomies. Sufficient blood should be removed to maintain the hematocrit below 45%.
ASA
100 mg/daily of ASA is recommended (when there are not contraindications) according with current guidelines for this risk class of patients
Interventions
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AOP2014
AOP2014 will be supplied to the patients as pre-filled auto-injection pens, containing 250 µg of active drug (0.5 ml solution for injection). One pen may be used twice within a time period of 4 weeks. Hence investigators will provide one prefilled pen at every monthly visit. AOP2014 will be self-injected subcutaneously by patients once every 14 days at the single doses of 100 µg (0.2 ml).
Phlebotomies
According to current common clinical practice the regimen must be selected accordingly to maintain the recommended level of HCT\< 45%. Once normalization of the hematocrit has been achieved, blood counts at regular intervals (every 4 weeks) will establish the frequency of future phlebotomies. Sufficient blood should be removed to maintain the hematocrit below 45%.
ASA
100 mg/daily of ASA is recommended (when there are not contraindications) according with current guidelines for this risk class of patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Polycythemia Vera according to World Health Organization 2016 criteria
* Diagnosis of Polycythemia Vera including a recent bone marrow (BM) biopsy (performed within 3 years prior randomization in the study) and never treated with cytoreductive drugs
* HCT\<45%
* Ability and willingness to comply with all study requirements
* Signed written informed consent.
Exclusion Criteria
* Previous cytoreductive drugs
* Known hypersensitivity or contraindications to the Investigational Medicinal Product (Pegylated Proline-Interferon alpha-2b) including:
evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension); thyroid dysfunction not adequately controlled; patients tested positively with Thyroglobulin antibody and / or TPOAb at screening; documented autoimmune disease at screening or in the medical history; history or presence of depression requiring treatment with antidepressant; any risk of suicide at screening or previous suicide attempts;
* Previous exposure to a non-pegylated or pegylated interferon α
* Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis
* Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
* Significant liver (AST or alanine aminotransferase \> 2.5 times ULN) or renal disease (creatinine \> 2 mg/ml)
* Presence of any life-threatening condition or of any disease (e.g. cancer) that is likely to significantly shorten life expectancy
* History of active substance or alcohol abuse within the last year
* Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol
* Pregnant or lactating women and women\*/men of childbearing potential who are not using or are not willing to use any effective means of contraception (i.e. sexual abstinence, hormonal contraceptive, intra-uterine device, barrier method such as diaphragms or condoms, surgical methods).
* Pregnancy test will be performed in order to ascertain negativity of human chorionic gonadotropin (β-hCG) test and confirm that childbearing women are not pregnant.
18 Years
60 Years
ALL
No
Sponsors
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AOP Orphan Pharmaceuticals AG
INDUSTRY
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
OTHER
Responsible Party
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Principal Investigators
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Tiziano Barbui, Professor
Role: STUDY_CHAIR
Fondazione per la Ricerca Ospedale Maggiore di Bergamo (FROM)
Locations
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U.O. Ematologia, Ospedale Casa Sollievo della Sofferenza Istituto di Ricovero e Cura a Carattere Scientifico
San Giovanni Rotondo, (FG) Puglia, Italy
U.O. Ematologia con Trapianto, Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari
Bari, Apulia, Italy
Azienda Ospedaliera Universitaria Federico II di Napoli
Napoli, Campania, Italy
Divisione Ematologia Policlinico S. Orsola - Malpighi
Bologna, Emilia-Romagna, Italy
Clinica Ematologica, Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"
Udine, Friuli Venezia Giulia, Italy
UCSC Ematologia, Fondazione Policlinico Universitario "Agostino Gemelli"Università Cattolica del Sacro Cuore
Rome, Lazio, Italy
UOC Ematologia, ASST Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Divisione Oncoematologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Divisione Ematologia ASST, Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Divisione Ematologia, ASST di MONZA - Ospedale San Gerardo di Monza
Monza, Lombardy, Italy
Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese
Varese, Lombardy, Italy
S.C. Ematologia Azienda Ospedaliera S. Croce e Carle Cuneo
Cuneo, Piedmont, Italy
SCDU Ematologia, A.O.U. Maggiore della Carità
Novara, Piedmont, Italy
S.C. Ematologia, AOU- Presidio Ospedaliero Molinette
Turin, Piedmont, Italy
Unità Operativa Complessa di Emostasi Azienda Ospedaliero-Universitario "Policlinico Vittorio-Emanuele - Presidio Ospedaliero Ferrarotto
Catania, Sicily, Italy
UOC Ematologia, Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Messina, Sicily, Italy
Divisione Ematologia Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" Palermo
Palermo, Sicily, Italy
SOD Ematologia AUOC Azienda Ospedaliero-Universitaria "Careggi"
Florence, Tuscany, Italy
Clinica Medica I Azienda Ospedaliera di Padova
Padua, Veneto, Italy
Divisione Ematologia, Ospedale Borgo Roma
Verona, Veneto, Italy
Divisione Ematologia, Ospedale San Bortolo
Vicenza, Veneto, Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Countries
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References
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Barbui T, Vannucchi AM, De Stefano V, Carobbio A, Ghirardi A, Carioli G, Masciulli A, Rossi E, Ciceri F, Bonifacio M, Iurlo A, Palandri F, Benevolo G, Pane F, Ricco A, Carli G, Caramella M, Rapezzi D, Musolino C, Siragusa S, Rumi E, Patriarca A, Cascavilla N, Mora B, Cacciola E, Mannarelli C, Loscocco GG, Guglielmelli P, Gesullo F, Betti S, Lunghi F, Scaffidi L, Bucelli C, Vianelli N, Bellini M, Finazzi MC, Tognoni G, Rambaldi A. Ropeginterferon versus Standard Therapy for Low-Risk Patients with Polycythemia Vera. NEJM Evid. 2023 Jun;2(6):EVIDoa2200335. doi: 10.1056/EVIDoa2200335. Epub 2023 May 15.
Barbui T, Vannucchi AM, De Stefano V, Masciulli A, Carobbio A, Ferrari A, Ghirardi A, Rossi E, Ciceri F, Bonifacio M, Iurlo A, Palandri F, Benevolo G, Pane F, Ricco A, Carli G, Caramella M, Rapezzi D, Musolino C, Siragusa S, Rumi E, Patriarca A, Cascavilla N, Mora B, Cacciola E, Mannarelli C, Loscocco GG, Guglielmelli P, Betti S, Lunghi F, Scaffidi L, Bucelli C, Vianelli N, Bellini M, Finazzi MC, Tognoni G, Rambaldi A. Ropeginterferon alfa-2b versus phlebotomy in low-risk patients with polycythaemia vera (Low-PV study): a multicentre, randomised phase 2 trial. Lancet Haematol. 2021 Mar;8(3):e175-e184. doi: 10.1016/S2352-3026(20)30373-2. Epub 2021 Jan 18.
Kiladjian JJ, Barbui T. From leeches to interferon: should cytoreduction be prescribed for all patients with polycythemia vera? Leukemia. 2020 Nov;34(11):2837-2839. doi: 10.1038/s41375-020-0984-9. Epub 2020 Jul 16. No abstract available.
Other Identifiers
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Low-PV
Identifier Type: -
Identifier Source: org_study_id
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