WHO ICTRP trial

An unblinded, multi-center study evaluating long-term treatment with…

EUCTR2020-000547-31-IT · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2020-000547-31-IT
Public title An unblinded, multi-center study evaluating long-term treatment with Zanubrutinib (BGB-3111) regimens in patients with blood cancer in the lymph nodes
Scientific title An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients with B cell Malignancies - n/a
Primary sponsor BeiGene Ltd.
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): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries United States;Korea, Democratic People's Republic of;Australia;United Kingdom;New Zealand;China;Italy;Korea, Republic of
Conditions B-cell malignancies MedDRA version: 20.0 Level: LLT Classification code 10003901 Term: B-cell lymphoma NOS System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
Interventions Product Name: Zanubrutinib Product Code: [BGB-3111] Pharmaceutical Form: Capsule, hard INN or Proposed INN: Zanubrutinib CAS Number: 1691249-45-2 Current Sponsor code: BGB-3111 Concentration unit: mg milligram(s) Concentration type: equal…
Registration date Oct 22, 2020
Target size 500
Secondary IDs BGB-3111-LTE1;Zanubrutinib;2020-000547-31-GB
Registry page clinicaltrialsregister.eu

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