WHO ICTRP trial

EWALL-PH-03: An open label, 2-arm, Randomised phase II study to Compare the…

CTIS2023-505330-95-01 · EU Clinical Trials Information System · Not Recruiting

Key facts

Trial ID CTIS2023-505330-95-01
Public title EWALL-PH-03: An open label, 2-arm, Randomised phase II study to Compare the Safety and Efficacy of Ponatinib plus Chemotherapy with Imatinib plus Chemotherapy as front-line therapy for patients aged 55 years and over with Philadelphia chromosome positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)
Scientific title EWALL-PH-03: An open label, 2-arm, Randomised phase II study to Compare the Safety and Efficacy of Ponatinib plus Chemotherapy with Imatinib plus Chemotherapy as front-line therapy for patients aged 55 years and over with Philadelphia chromosome positive (Ph+ or BCR-ABL+) Acute Lymphoblastic…
Primary sponsor Cardiff University
Registry EU Clinical Trials Information System
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): Yes Therapeutic confirmatory - (Phase III): No Therapeutic use - (Phase IV): No
Countries Sweden;Finland;France
Conditions Blood cancer MedDRA version: 21.0Level: LLTClassification code: 10000845Term: Acute lymphoblastic leukemia Class: 10029104;Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
Interventions Product Name: Iclusig 15 mg film-coated tablets, Product Code:PRD4563018, Pharmaceutical Form: FILM-COATED TABLET, Other descriptive name: , Strength: , Product Name: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution…
Registration date Jan 16, 2025
Target size 100
Secondary IDs NCT04688983;2018-003350-25
Registry page euclinicaltrials.eu

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