WHO ICTRP trial

The effectivness and safety of ponatinib administered in combination with…

EUCTR2019-004540-29-CZ · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2019-004540-29-CZ
Public title The effectivness and safety of ponatinib administered in combination with reduced chemotherapy in treatment of acute lymphoblastic leukemia in adults.
Scientific title Ponatinib plus reduced-intensity chemotherapy in the first-line treatment of adult patients with Ph-positive acute lymphoblastic leukemia - Pona-CELL
Primary sponsor Ústav hematologie a krevní transfuze
Registry EU Clinical Trials Register
Recruitment status Authorised
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 Czech Republic
Conditions NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA MedDRA version: 21.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864 ;Therapeutic area: Diseases [C]…
Interventions Trade Name: ICLUSIG 15 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ponatinib CAS Number: 943319-70-8 Other descriptive name: PONATINIB Concentration unit: mg milligram(s) Concentration type: range…
Registration date Jul 7, 2020
Target size 32
Secondary IDs Pona-CELL
Registry page clinicaltrialsregister.eu

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