Clinical trials: Polycythemia, Primary
Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF)
Managed Access Programs for INC424, Ruxolitinib
The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib
- Conditions
- Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF), Thrombocythemia Myelofibrosis (PET-MF), Severe/Very Severe COVID-19 Illness
- Trial name
- NCT04745637
- Testing
- Ruxolitinib
- Sponsor
- Novartis Pharmaceuticals
Primary Myelofibrosis, Post-Polycythemia Vera
Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis
The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite of clonal disorders of pluripotent hematopoietic…
- Conditions
- Primary Myelofibrosis, Post-Polycythemia Vera, Post-Essential Thrombocythemia Myelofibrosis
- Trial name
- NCT01423058
- Testing
- Momelotinib
- Where
- 6 sites in United States, Canada
- Volunteers
- 61 people
- Sponsor
- Sierra Oncology LLC - a GSK company
Hematopoietic Neoplasm
Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia
Primary Objective: Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria)…
- Trial name
- NCT01420783
- Testing
- SAR302503
- Where
- 35 sites in United States, Australia and 7 more
- Volunteers
- 81 people
- Sponsor
- Bristol-Myers Squibb
Polycythemia Vera
Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)
This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension.
- Trial name
- NCT04057040
- Testing
- PTG-300
- Where
- 16 sites in United States, India
- Volunteers
- 70 people
- Sponsor
- Protagonist Therapeutics, Inc.
Myelofibrosis
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease
The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of idelalisib in adults receiving ruxolitinib as therapy for intermediate to high-risk primary myelofibrosis (PMF)…
- Trial name
- Madison (NCT02436135)
- Testing
- Idelalisib, Ruxolitinib
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Gilead Sciences
Thrombocythemia, Essential, Primary Myelofibrosis
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data.
- Conditions
- Thrombocythemia, Essential, Primary Myelofibrosis, Myelofibrosis, Post-polycythemia Vera Myelofibrosis
- Trial name
- NCT06351631
- Testing
- Bomedemstat
- Where
- 21 sites in United States, Australia and 4 more
- Volunteers
- 400 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Myelofibrosis, Post-Polycythemia Vera
An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate…
- Conditions
- Primary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis
- Trial name
- FREEDOM2 (NCT03952039)
- Testing
- FEDRATINIB, Best Available Therapy (BAT)
- Where
- 107 sites in Australia, Austria and 14 more
- Volunteers
- 202 people
- Sponsor
- Celgene
Myelofibrosis
Clinical Trial of Aplidin® in Patients With Primary Myelofibrosis
This is an open-label, Phase II Clinical Trial of Aplidin® (plitidepsin) in Patients with Primary Myelofibrosis and post polycythemia vera/essential thrombocythemia (Post-PV/ET) Myelofibrosis.
- Trial name
- NCT01149681
- Testing
- APLIDIN (plitidepsin)
- Where
- 2 sites in United States, Italy
- Volunteers
- 12 people
- Sponsor
- PharmaMar
Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)
Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages.
- Conditions
- Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)
- Trial name
- NCT04878003
- Testing
- KRT-232, TL-895
- Where
- 29 sites in United States, Belarus and 7 more
- Volunteers
- 52 people
- Sponsor
- Kartos Therapeutics, Inc.
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
The purpose of this Phase 2 study is to evaluate the efficacy and safety of momelotinib (MMB) in combination with luspatercept (LUSPA) in participants with transfusion dependence (TD) primary myelofibrosis (PMF) or…
- Trial name
- ODYSSEY (NCT06517875)
- Testing
- Momelotinib, Luspatercept
- Where
- 33 sites in United States, Canada and 4 more
- Volunteers
- 68 people
- Sponsor
- GlaxoSmithKline
Polycythemia Vera
Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera
Phase III study to compare the efficacy and safety of the novel monopegylated interferon alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One year treatment of patients with polycythemia vera.
- Trial name
- PROUD-PV (NCT01949805)
- Testing
- Peg-P-IFN-alpha-2b (AOP2014), Hydroxyurea
- Where
- 58 sites in Austria, Belgium and 12 more
- Volunteers
- 257 people
- Sponsor
- AOP Orphan Pharmaceuticals AG
Myelofibrosis
Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis
This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with primary myelofibrosis (PMF) and post polycythemia vera or post…
- Trial name
- NCT01369498
- Testing
- Simtuzumab, Ruxolitinib
- Where
- 7 sites in United States
- Volunteers
- 54 people
- Sponsor
- Gilead Sciences
Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis
Phase 2 Study: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis Previously Treated With Ruxolitinib
This was an open-label, randomized, dose-finding study in patients with primary or secondary MF (Dynamic International Prognostic Scoring System [DIPSS] risk score of Intermediate-1 to High-Risk) who were previously treated with…
- Conditions
- Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post- Essential Thrombocythemia Myelofibrosis
- Trial name
- NCT04884191
- Testing
- Pacritinib
- Where
- 62 sites in United States, France and 6 more
- Volunteers
- 165 people
- Sponsor
- CTI BioPharma
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis
Pacritinib Versus Best Available Therapy to Treat Myelofibrosis
Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.
- Conditions
- Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Trial name
- NCT01773187
- Testing
- Pacritinib, Best Available Therapy
- Where
- 81 sites in United States, Australia and 10 more
- Volunteers
- 327 people
- Sponsor
- CTI BioPharma
Primary Myelofibrosis (PMF), Post-polycythemia Vera (Post-PV)
Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF
This study is to determine the efficacy of momelotinib (MMB) versus best available therapy (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or post-polycythemia vera or post-essential thrombocythemia…
- Conditions
- Primary Myelofibrosis (PMF), Post-polycythemia Vera (Post-PV), Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
- Trial name
- Simplify 2 (NCT02101268)
- Testing
- Momelotinib, Best Available Therapy (BAT)
- Where
- 48 sites in United States, Canada and 6 more
- Volunteers
- 156 people
- Sponsor
- Sierra Oncology LLC - a GSK company
Myelofibrosis; Anemia, Anemia
Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia
This phase 1b/2a open-label study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of DISC-0974 as well as categorize the effects on hematologic response in participants with…
- Conditions
- Myelofibrosis; Anemia, Anemia, Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera
- Trial name
- NCT05320198
- Testing
- DISC-0974
- Where
- 35 sites in United States, Australia
- Volunteers
- 150 people
- Sponsor
- Disc Medicine, Inc
Polycythemia Vera
Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy.
This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and did not have a palpable spleen.
- Trial name
- RESPONSE-2 (NCT02038036)
- Testing
- Best Available Therapy, Ruxolitinib
- Where
- 48 sites in Australia, Belgium and 10 more
- Volunteers
- 149 people
- Sponsor
- Novartis Pharmaceuticals
Polycythemia Vera
Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)
This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of…
- Trial name
- NCT01243944
- Testing
- ruxolitinib tablets, Best Available Therapy (BAT)
- Where
- 102 sites in United States, Argentina and 16 more
- Volunteers
- 222 people
- Sponsor
- Incyte Corporation
Polycythemia Vera
Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.
The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) was to provide early access to ruxolitinib and evaluate safety information in patients with polycythemia vera (PV) who were hydroxyurea…
- Trial name
- NCT02292446
- Testing
- Ruxolitinib
- Where
- 65 sites in Austria, Belgium and 10 more
- Volunteers
- 161 people
- Sponsor
- Novartis Pharmaceuticals
Myeloproliferative Disorders, Myelofibrosis
A Safety Study of XL019 in Adults With Myelofibrosis
The purpose of this study is to evaluate the safety and tolerability of XL019 in adults with myelofibrosis. XL019 is a selective inhibitor of the cytoplasmic tyrosine kinase JAK2.
- Conditions
- Myeloproliferative Disorders, Myelofibrosis, Polycythemia Vera, Thrombocythemia, Essential
- Trial name
- NCT00522574
- Testing
- XL019
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Exelixis