- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05269771
MAP to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera
Treatment Plan for Managed Access Program (MAP) to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera (PV)
Study Overview
Detailed Description
Study Type
Expanded Access Type
- Individual Patients
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:
- Male or female aged 12 or over
- Confirmed diagnosis of PV based on World Health Organization (WHO) criteria
- Patients must have a treatment history for PV that meets the definition of resistance or intolerance to hydroxyurea (HU) or other cytoreductive therapy
- Patients with a peripheral blood blast count of 0% at screening
- Patients must have recovered or stabilized sufficiently from adverse drug reactions associated with prior treatments before beginning treatment with ruxolitinib
- Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 Written patient informed consent must be obtained prior to start of treatment.
Exclusion Criteria:
Patients eligible for this Treatment Plan must not meet any of the following criteria:
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
- Presence of an active uncontrolled infection including significant bacterial, fungal, viral (including CMV, EBV, HHV-6, HBV, HCV, BK or HIV) or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. Patients with inactive chronic infection (without viral replication) can be enrolled.
- History of progressive multifocal leuko-encephalopathy (PML).
- Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8 μmol/L), or have estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are
- women whose sexual orientation precludes intercourse with a male partner.
- women whose partners have been sterilized by vasectomy or other means.
- using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable throughout the period of treatment and 30 days after treatment discontinuation.
Any female aged 8 years and above is to be treated as a woman of child-bearing potential.
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [for US only: and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- Pregnancy
- Not able to understand and to comply with treatment instructions and requirements
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CINC424B2002I
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polycythemia Vera
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PharmaEssentia Japan K.K.RecruitingPolycythemia Vera (PV)Japan
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Novartis PharmaceuticalsCompletedPolycythemia Vera (PV)United States
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Memorial Sloan Kettering Cancer CenterEli Lilly and Company; Incyte CorporationRecruitingMyelofibrosis Due to and Following Polycythemia VeraUnited States
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PharmaEssentia Japan K.K.Recruiting
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PharmaEssentia Japan K.K.CompletedPolycythemia Vera (PV)Japan
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Northwestern UniversityNational Cancer Institute (NCI); Celgene; The Leukemia and Lymphoma SocietyWithdrawnPrimary Myelofibrosis | Polycythemia Vera, Post-Polycythemic Myelofibrosis PhaseUnited States
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Ionis Pharmaceuticals, Inc.RecruitingPhlebotomy Dependent Polycythemia VeraUnited States, Canada, Hungary, United Kingdom, Australia, Poland
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Novartis PharmaceuticalsTerminatedPrimary Myelofibrosis | Post-Polycythemia Vera | Post-Essential ThrombocytopeniaUnited States
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CelgeneRecruitingPrimary Myelofibrosis | Myeloproliferative Disorders | Anemia | Myelofibrosis | Post-Polycythemia Vera MyelofibrosisFrance, Belgium, Spain, Australia, Canada, United States, Korea, Republic of, Romania, Japan, Israel, Italy, Austria, China, Czechia, Germany, Greece, Ireland, Poland, United Kingdom, Hong Kong, Hungary, Lebanon, Argentina, Chile, Colombia and more
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CelgeneImpact Biomedicines, Inc., a wholly owned subsidiary of Celgene CorporationActive, not recruitingPrimary Myelofibrosis | Myelofibrosis | Post-Polycythemia VeraAustralia, Austria, Belgium, China, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Ireland, United Kingdom
Clinical Trials on Ruxolitinib
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First Affiliated Hospital of Zhejiang UniversityXiangya Hospital of Central South University; Second Affiliated Hospital, School... and other collaboratorsRecruitingHematologic Malignancy | Bronchiolitis Obliterans SyndromeChina
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Novartis PharmaceuticalsTerminatedMyelofibrosis With High Molecular Risk MutationsBelgium, Spain, United Kingdom, Hungary, Italy, Japan, Taiwan, Germany, Canada, Singapore, Austria, Australia, France, Israel, Sweden, Switzerland, Hong Kong, Greece, Turkey, Brazil, Russian Federation, Denmark, Portugal, Norway, Poland
-
Incyte CorporationCompleted
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University of ZurichIncyte CorporationNot yet recruitingExanthema | Lichenoid Skin Rashes Under Anti-PD1 Tumor Therapy
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Beijing Friendship HospitalUnknownHemophagocytic LymphohistiocytosisChina
-
Julie NangiaIncyte Corporation; Translational Breast Cancer Research ConsortiumRecruitingDuctal Carcinoma In Situ | Atypical Ductal Hyperplasia | Atypical Lobular Hyperplasia | Lobular Carcinoma In SituUnited States
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National Heart, Lung, and Blood Institute (NHLBI)RecruitingSevere Aplastic Anemia | Single Lineage Cytopenias, T-LGL | Hypoplastic MDSUnited States
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Qilu Hospital of Shandong UniversityRecruiting
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Memorial Sloan Kettering Cancer CenterDana-Farber Cancer Institute; Thomas Jefferson University; Cornell UniversityRecruiting
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Children's Hospital Medical Center, CincinnatiCompletedSolid Organ Transplant | Acute-graft-versus-host Disease | Chronic Graft-versus-host-diseaseUnited States