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BGB-11417-101 - A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients with Mature B-Cell Malignancies.

Studio Clinico

Patologia: Linfomi, Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, I B

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Confirmed diagnosis of one of the following:

NHL Cohorts:
1. MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least one prior therapy ii. Active disease requiring treatment
2. FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy
3. DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least two prior systemic therapies and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy)
4. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Part 1

CLL/SLL Cohorts:
5. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy ii. Requiring treatment as defined by history

MCL cohorts:
6.WHO-defined MCL I. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the investigatorr

WM cohorts:
g. WHO-defined WM (clinical and definitive histologic diagnosis) i. R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy; ii. Meeting at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's Macroglobulinemia (Dimopoulos et al 2014)

- Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI), defined as:
    1. CLL: at least 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes measured by flow cytometry
    2. DLBCL, FL, MZL, SLL: at least 1 lymph node > 1.5 cm in longest diameter OR 1 extranodal lesion > 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable for this study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function
- Adequate pancreatic function indicated by:
    1. Serum amylase ≤ 1.5 x upper limit of normal (ULN)
    2. Serum lipase ≤ 1.5 x ULN.

Criteri di esclusione: 

- Known central nervous system involvement by lymphoma/leukemia
- Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
- Prior therapy ≥ 2 months with or progression on a B-cell lymphoma-2 (Bcl-2) inhibitor

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

Trattamento sperimentale: 

BGB-11417 (Sonrotoclax);
BGB-11417 (Sonrotoclax) + Zanubrutinib;
BGB-11417 (Sonrotoclax) + Obinotuzumab +/- Zanubrutinib.

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

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

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

Riferimento: Prof. Paolo Ghia
Email: segreteriallc@hsr.it

 

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

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

 

AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR
Ematologia

 

Centro Italia

Azienda Ospedaliera di Perugia
Via Dottori 1 - 06132 Perugia - PG
AOU Santa Maria della Misericordia

Riferimento: Dr. Paolo Sportoletti
Email: paolo.sportoletti@unipg.it

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
NB: Arruolamento pazienti non ancora attivo

Email: ematologia@policlinicogemelli.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-004641-37

Data di inserimento: 30.05.2024

Promotore

BeiGene

Principal Investigator ITALIA

IRCCS Ospedale San Raffaele, Milano

Riferimento: Prof. Paolo Ghia

Telefono: 00000

Email: segreteriallc@hsr.it

Localita: Milano

 

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