ServiziMenu principale

<< Torna a "Tutti gli studi"

BGB-3111-LTE1 - An Open-label, Multi-center, Monotherapy, Long-term Extension Study of Zanubrutinib (BGB-3111) in Patients with B-cell Malignancies.

Studio Clinico

Patologia: Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: Non applicabile

Linee di trattamento: Non applicabile

Criteri di inclusione: 

1. Currently participating or participated recently in a BeiGene parent study
2. Intent to continue or start zanubrutinib treatment after any of the following:
    a. At time of final analysis or study closure of the eligible BeiGene parent study
    b. At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
    c. At an alternative timepoint for an alternative reason
3. Patient who is currently on zanubrutinib treatment:
Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment
4. Zanubrutinib-naive patient:
Must meet the following criteria ≤ 15 days before first dose of study drug:
    a. Platelets ≥ 50,000/mm3
    b.Absolute neutrophil count ≥ 750/mm3
    c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
    d. Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome)
    e. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec
    f. No known New York Heart Association (NYHA) Class III or IV congestive heart failure
    g.Creatinine clearance ≥ 30 mL/min
5. Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.

Criteri di esclusione: 

1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, non- compliance with study procedures, or withdrawal of consent
2. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
3. Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk
4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol
5. Pregnant or lactating woman
6. Inability to comply with study procedures
7. Concurrent participation in another therapeutic clinical study
8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trattamento sperimentale: 

Zanubrutinib (BGB-3111).

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
UOC Ematologia

 

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr.ssa Michela Ceccolini
Email: michela.ceccolini@irst.emr.it

 

Grande Ospedale Metropolitano Niguarda
Piazza Ospedale Maggiore 3 - 20162 Milano - MI
Ematologia

Email: ematologia@ospedaleniguarda.it

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO
SC Ematologia

Riferimento: Prof. Roberto Marasca
Email: roberto.marasca@unimore.it

 

A.O.U. Maggiore della Carità
Corso Mazzini 18 - 28100 Novara - NO
Ematologia

Email: ematologia.segre@maggioreosp.novara.it

 

IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV
SC Ematologia 1

Email: ematologia@smatteo.pv.it

 

Ospedale S. Maria delle Croci, Ravenna
Viale Randi 5 - 48121 Ravenna - RA
UO di Ematologia

Riferimento: Dr.ssa Monica Tani
Email: monica.tani@auslromagna.it

 

AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO
Ematologia

Email: ematologia@cittadellasalute.to.it

 

Azienda Ospedaliera Santa Maria della Misericordia
Piazzale Santa Maria della Misericordia 15 - 33100 Udine - UD
Clinica Ematologica

Riferimento: Dr. Jacopo Olivieri
Email: jacopo.olivieri@asufc.sanita.fvg.it

 

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
UOC Ematologia e Trapianto di cellule staminali emopoietiche

Email: ematologia@policlinicogemelli.it

 

AO S. Maria Terni
Via Tristano di Joannuccio 1 - 05100 Terni - TR

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-511267-28-00 - NCT04170283

Data di inserimento: 24.05.2024

Promotore

BeiGene

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

<< Torna a "Tutti gli studi"

Apri