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
44335
clinical trials with a EudraCT protocol, of which
7366
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 ).
14 result(s) found for: Extramedullary hematopoiesis.
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EudraCT Number: 2013-002707-33
Sponsor Protocol Number: GS-US-352-0101
Start Date*: 2014-05-27
Sponsor Name:Sierra Oncology, Inc.
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: A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
Medical condition: Acute Lymphoblastic Leukemia (ALL)
Lymphoblastic Lymphoma
Disease:
Population Age: Children, Adolescents, Under 18, Adults, Elderly
Sponsor Name:Therapeutic Advances in Childhood Leukemia Consortium (TACL)
Full Title: A TACL Phase 1/2 Study of PO Ixazomib in Combination with Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Medical condition: Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma
(LLy)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000004864
10000845
Acute lymphoblastic leukemia
LLT
20.0
100000004864
10065923
Lymphoblastic lymphoma
LLT
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults
Full Title: An Open-Label Extension Study to Evaluate the Long-Term Effects of ACE-536 in Patients with β-Thalassemia Previously Enrolled in Study A536-04
Medical condition: β-Thalassemia Intermedia and β-Thalassemia major
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)
Full Title: A PHASE 2, PROSPECTIVE, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, ACTIVE- CONTROL, PARALLEL-GROUP STUDY TO DETERMINE THE SAFETY OF AND TO SELECT A TREATMENT REGIMEN OF CC-4047 EITHER AS SINGLE-AGENT O...
Medical condition: Myelofibrosis with myeloid metaplasia
Full Title: A Phase 2, Prospective Study Of PRM-151 In Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), Or Post-Essential Thrombocythemia MF (post-ET MF)
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
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
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sponsor Name:Pfizer Inc. 235 East 42nd Street, New York, 10017
Full Title: A phase 2, double-blind, randomized safety and efficacy study of Glasdegib (PF-04449913) versus placebo in patients with Myelofibrosis previously treated with ruxolitinib.
Medical condition: Myelofibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
19.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: A Phase Ib/III, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of vismodegib in combination with ruxolitinib versus placebo and ruxolitinib in patients with ...
Medical condition: Intermediate- or high-risk myelofibrosis
Disease:
Version
SOC Term
Classification Code
Term
Level
19.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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: 2011-001897-25
Sponsor Protocol Number: EFC12153
Start Date*: 2011-12-21
Sponsor Name:sanofi-aventis recherche & développement
Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibros...
Medical condition: Primary myelofibrosis, post-polycythemia vera myelofibrosis, or post- essential thrombocythemia myelofibrosis
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)
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