AN ITALIAN RETROSPECTIVE-PROSPECTIVE OBSERVATIONAL STUDY ON THE USE OF ZANUBRUTINIB IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (AZALEA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000437
• EU PAS number:
  EUPAS1000000437
• Study ID:
  1000000437
• Official title and acronym:
  AN ITALIAN RETROSPECTIVE-PROSPECTIVE OBSERVATIONAL STUDY ON THE USE OF ZANUBRUTINIB IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (AZALEA)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This retrospective-prospective observational study is designed to collect information on the population of treatment-naive (TN) or relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) patients treated with zanubrutinib and clinical outcome of patients who received treatment according to the legislative decree on compassionate use (cohort A, retrospective and prospective study) and to collect information on the population of CLL patients treated with zanubrutinib in clinical practice who start treatment with zanubrutinib from the beginning of the study (cohort B, prospective only study).
• Study status:
  Ongoing

Research institutions and networks

Institutions

BeiGene

OSPEDALE A. PERRINO-BRINDISI
OSPEDALI RIUNITI DELLE MARCHE
ARCISPEDALE SANT'ANNA, FERRARA
AOOR VILLA SOFIA-CERVELLO
AZIENDA OSPEDALIERA NAZIONALE SS.ANTONIO E BIAGIO E CESARE ARRIGO
ARNAS GARIBALDI, PRESIDIO OSPEDALIERO NESIMA
AZIENDA OSPEDALIERA DI PADOVA
OSPEDALE DI BUSTO ARSIZIO
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
AZIENDA OSPEDALIERO UNIVERSITARIA PISANA
ISTITUTO EUROPEO DI ONCOLOGIA
FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
ISTITUTO ROMAGNOLO PER LO STUDIO DEI TUMORI "DINO AMADORI" - IRST
UNIVERSITA DEGLI STUDI DI MODENA-AZIENDA OSPEDALIERE POLICLINCO
AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO SANT'ORSOLA MALPIGHI
AZIENDA SANITARIA UNIVERSITARIA GIULIANO-ISONTINA
AZIENDA OSPEDALIERA POLICLINICO DI BARI
AZIENDA OSPEDALIERA S MARIA DI TERNI
ARCISPEDALE S. MARIA NUOVA - AUSL REGGIO EMILIA - ONCOLOGIA
OSPEDALE SANTA MARIA DELLA MISERICORDIA
AZIENDA OSPEDALIERA CITTÀ DELLA SALUTE E DELLA SCIENZA DI TORINO
CRO IRCCS AVIANO
AO BROTZU - OSPEDALE ONCOLOGICO ARMANDO BUSINCO
AOU MAGGIORE DELLA CARITA
AOU CAREGGI, SERVIZIO SANITARIO TOSCANA
AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO UMBERTO I - UNIVERSITÀ DI ROMA LA SAPIENZA
AZIENDA SOCIO SANITARIA TERRITORIALE GRANDE OSPEDALE METROPOLITANO NIGUARDA
FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO
OSPEDALE SAN RAFFAELE
AO CARDINALE G. PANICO
AZIENDA OSPEDALIERA SANT'ANNA E SAN SEBASTIANO
A.R.N.A.S. OSPEDALI CIVICO DI CRISTINA BENFRATELLI
OSPEDALE SAN GIOVANNI DI DIO E RUGGI D'ARAGONA
AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO TOR VERGATA

Study timelines

Date when funding contract was signed

Planned: 31/01/2024

Actual: 31/01/2024

Study start date

Planned: 01/03/2025

Actual: 26/02/2025

Date of final study report

Planned: 30/06/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

BeiGene (Italy) S.r.l.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

BGB-3111-MA-IT-401