interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).
The EU Clinical Trials Register currently displays
44394
clinical trials with a EudraCT protocol, of which
7406
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see
Frequently Asked Questions ).
Full Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Luspatercept (ACE-536) in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia With and With...
Medical condition: Anemia associated with myeloproliferative neoplasm (MPN)-associated
myelofibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10077161
Primary myelofibrosis
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074689
Post polycythemia vera myelofibrosis
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074690
Post essential thrombocythemia myelofibrosis
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074692
Post essential thrombocythaemia myelofibrosis
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074691
Post polycythaemia vera myelofibrosis
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028537
Myelofibrosis
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)IT(Completed)
Full Title: A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects with Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligibl...
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028537
Myelofibrosis
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:FR(Trial now transitioned)DE(Ongoing)HU(Completed)BE(Trial now transitioned)BG(Trial now transitioned)PL(Trial now transitioned)IT(Trial now transitioned)HR(Completed)
Trial results:(No results available)
EudraCT Number: 2017-001772-28
Sponsor Protocol Number: PAC203
Start Date*: 2017-10-23
Sponsor Name:CTI BioPharma Corp.
Full Title: Phase 3 Study (PACIFICA): A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essent...
Medical condition: Primary Myelofibrosis, Post-essential thrombocythemia myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/µL), Post polycythaemia vera myelofibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10077161
Primary myelofibrosis
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074692
Post essential thrombocythaemia myelofibrosis
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074691
Post polycythaemia vera myelofibrosis
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028537
Myelofibrosis
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)HU(Completed)SE(Completed)ES(Completed)FR(Completed)IT(Completed)
Full Title: A Phase 3, Randomized Study to Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects with Primary Myelofibrosis, Post-polycythemia Vera Myelofibr...
Medical condition: Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sponsor Name:University Medical Center Hamburg-Eppendorf
Full Title: Ruxolitinib versus allogeneic stem cell transplantation for patients with myelofibrosis according to donor availability: A prospective phase II trial (MMM 02 study)
Medical condition: primary myelofibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: PACIFICA Phase 3: A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thro...
Medical condition: Primary Myelofibrosis, Post-essential thrombocythemia myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL), Post polycythaemia vera myelofibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10077161
Primary myelofibrosis
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074691
Post polycythaemia vera myelofibrosis
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074692
Post essential thrombocythaemia myelofibrosis
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:CZ(Trial now transitioned)HU(Trial now transitioned)ES(Ongoing)FR(Trial now transitioned)BG(Trial now transitioned)IT(Trial now transitioned)RO(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2019-000373-23
Sponsor Protocol Number: CINC424H12201
Start Date*: 2020-01-24
Sponsor Name:Novartis Pharma AG
Full Title: A randomized, open-label, phase I/II open platform study evaluating safety and efficacy of novel ruxolitinib combinations in myelofibrosis patients
Medical condition: PMF or PPV- MF, or PET- MF
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: An Open-Label, Phase 2a/2b Study of KRT-232 in Subjects With Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post–ET-MF) Who Have Failed P...
Medical condition: Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF(Post–ET-MF)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10077161
Primary myelofibrosis
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074689
Post polycythemia vera myelofibrosis
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074690
Post essential thrombocythemia myelofibrosis
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)DE(Trial now transitioned)CZ(Trial now transitioned)FR(Trial now transitioned)HU(Trial now transitioned)ES(Trial now transitioned)PL(Trial now transitioned)BG(Trial now transitioned)LT(Trial now transitioned)IT(Trial now transitioned)PT(Trial now transitioned)HR(Trial now transitioned)GR(Trial now transitioned)RO(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2011-001012-56
Sponsor Protocol Number: I3X-MC-JHTB
Start Date*: 2012-08-30
Sponsor Name:Eli Lilly and Company
Full Title: A Phase 2 Study of LY2784544 in Patients with Myeloproliferative Neoplasms
Medical condition: Myeloproliferative neoplasms (MPNs), myelofibrosis, essential thrombocythemia, and polycythemia vera
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10036061
Polycythemia vera
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028537
Myelofibrosis
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10015493
Essential thrombocythaemia
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:DE(Trial now transitioned)ES(Ongoing)SE(Completed)AT(Trial now transitioned)IT(Completed)
Trial results:(No results available)
EudraCT Number: 2019-000583-18
Sponsor Protocol Number: SRA-MMB-301
Start Date*: 2020-01-07
Sponsor Name:Sierra Oncology, Inc.
Full Title: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera...
Medical condition: Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028537
Myelofibrosis
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028538
Myelofibrosis with myelometaplasia
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074689
Post polycythemia vera myelofibrosis
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074690
Post essential thrombocythemia myelofibrosis
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074691
Post polycythaemia vera myelofibrosis
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074692
Post essential thrombocythaemia myelofibrosis
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10077161
Primary myelofibrosis
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)DE(Completed)SE(Completed)DK(Completed)FR(Completed)CZ(Completed)ES(Restarted)PL(Completed)HU(Completed)AT(Completed)IT(Completed)RO(Ongoing)
Full Title: A Multi-Center, Open Label Study to Assess the Safety, Steady State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients with Myelofibrosis
Medical condition: Myelofibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074692
Post essential thrombocythaemia myelofibrosis
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074691
Post polycythaemia vera myelofibrosis
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10077161
Primary myelofibrosis
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:DE(Completed)IT(Completed)GB(GB - no longer in EU/EEA)
Full Title: A multicenter phase II, open label, single arm study to evaluate the efficacy and safety of ruxolitinib in the treatment of anemic myelofibrosis patients
Medical condition: treatment of anemic myelofibrosis patients
Full Title: A phase 3B, open-label, single-arm, rollover study to evaluate long-term safety in subjects who have participated in other Luspatercept (ACE-536) clinical trials.
Medical condition: Prior participation on a clinical trial of luspatercept (ACE-536) in protocols eligible for participation in this study ACE-536-LTFU-001 with the following medical conditions:
- myelodysplastic syn...
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000004850
10074356
Non-transfusion dependent thalassemia
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10068361
MDS
LLT
20.1
100000004850
10054658
Thalassemia
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074689
Post polycythemia vera myelofibrosis
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074690
Post essential thrombocythemia myelofibrosis
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074691
Post polycythaemia vera myelofibrosis
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074692
Post essential thrombocythaemia myelofibrosis
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028537
Myelofibrosis
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10077161
Primary myelofibrosis
PT
20.0
100000004851
10002272
Anemia
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:DE(Trial now transitioned)SE(Trial now transitioned)NL(Trial now transitioned)GB(GB - no longer in EU/EEA)FR(Trial now transitioned)GR(Trial now transitioned)ES(Ongoing)BE(Completed)BG(Trial now transitioned)IT(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2017-005109-11
Sponsor Protocol Number: INCB39110-209
Start Date*: 2018-12-13
Sponsor Name:Incyte Corporation
Full Title: An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis
Medical condition: Myelofibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028537
Myelofibrosis
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074689
Post polycythemia vera myelofibrosis
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074690
Post essential thrombocythemia myelofibrosis
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074691
Post polycythaemia vera myelofibrosis
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074692
Post essential thrombocythaemia myelofibrosis
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients with Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 ...
Medical condition: Myeloproliferative Neoplasms (Myelofibrosis and Essential Thrombocythemia)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028537
Myelofibrosis
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10015494
Essential thrombocythemia
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)NL(Completed)BE(Completed)PL(Completed)IT(Completed)
Full Title: A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects with Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post- Essential Thromboc...
Medical condition: Primary Myleofibrosis (PMF) or post-Polycythemia vera or post-Essential Thrombocythemia Myelofibrosis (post-PV/ET MF)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: Open-label Study to Assess the Long-term Safety and Efficacy of Momelotinib in Subjects with Primary Myelofibrosis, Post polycythemia Vera Myelofibrosis, Post essential Thrombocythemia Myelofibros...
Medical condition: subjects with either primary myelofibrosis (PMF) or post polycythemia vera myelofibrosis or post essential thrombocythemia myelofibrosis (post-PV / ET MF) or polycythemia vera (PV) or essential thr...
Disease:
Version
SOC Term
Classification Code
Term
Level
17.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10036057
Polycythaemia vera
PT
17.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028537
Myelofibrosis
PT
17.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: Multi-Center Phase II Study with Pomalidomide in Patients with Myeloproliferative Neoplasms in Fibrotic Stage
Medical condition: This is a phase II, multi-center study of pomalidomide in adult patients with Primary myelofibrosis, Secondary myelofibrosis, and unclassifiable Myeloproliferative Neoplasms showing at least grade ...
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