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
44339
clinical trials with a EudraCT protocol, of which
7369
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
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2 result(s) found for: Leukemia cutis.
Displaying page 1 of 1.
EudraCT Number: 2018-001321-68
Sponsor Protocol Number: B1761026
Start Date*: 2018-05-22
Sponsor Name:Pfizer, Inc.
Full Title: Gemtuzumab Ozogamicin (mylotarg (registered)) Expanded Access Protocol For Treatment Of Patients In The United States With Relapsed/refractory Acute Myelogenous Leukemia Who May Benefit From Treatm...
Medical condition: Acute Myelogenous Leukemia, including myelodysplastic syndrome and acute promyelocytic leukemia
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10000880
Acute myeloid leukaemia
PT
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly
Full Title: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas
Medical condition: Advanced Solid Tumors and Lymphomas that are metastatic or unresectable: cohort 1:Recurrent/metastatic head and neck squamous cell carcinoma; cohort 2:Relapsed or refractory diffuse large B-cell ly...
Disease:
Version
SOC Term
Classification Code
Term
Level
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10012818
Diffuse large B-cell lymphoma
PT
22.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10011677
Cutaneous T-cell lymphoma
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10067821
Head and neck cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10008229
Cervical cancer
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10034623
Peripheral T-cell lymphoma unspecified
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:GB(Temporarily Halted)FR(Completed)HU(Completed)ES(Ongoing)BE(Completed)IT(Trial now transitioned)
Trial results:(No results available)
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• EEA CTAs: Date study was authorised to proceed • Outside EU/EEA: Date study was submitted in EudraCT