Phase
Condition
Neoplasms
Treatment
BGB-11417
Sonrotoclax
Zanubrutinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Confirmed diagnosis of one of the following:
NHL Cohorts:
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 requiringtreatment
FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors ofhematopoietic and lymphoid tissue) and defined as disease that relapsed after, orwas refractory to, at least 1 prior systemic therapy
DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease thatrelapsed after, or was refractory to, at least two prior systemic therapies and haseither progressed following or is not a candidate for autologous stem celltransplant (due to comorbidities or non-responsiveness to salvage chemotherapy)
Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 thathas transformed into a more aggressive lymphoma. Patients with transformation fromCLL or SLL (Richter's transformation) are not eligible for Part 1 CLL/SLL Cohorts:
CLL/SLL diagnosis that meets the International Workshop on Chronic LymphocyticLeukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/Rdisease defined as disease that relapsed after, or was refractory to, at least 1prior therapy ii. Requiring treatment as defined by history MCL cohorts:
WHO-defined MCL i. R/R MCL defined as disease that relapsed after, or was refractoryto, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of theinvestigator
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:
CLL: at least 1 lymph node > 1.5 cm in longest diameter and measurable in 2perpendicular dimensions or clonal lymphocytes measured by flow cytometry
DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node > 1.5 cm in longest diameterOR 1 extranodal lesion > 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is consideredmeasurable for this study
WM: serum immunoglobulin (Ig) M level > 0.5 g/dL
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Adequate organ function
Adequate pancreatic function indicated by:
Serum amylase ≤ 1.5 x upper limit of normal (ULN)
Serum lipase ≤ 1.5 x ULN
Exclusion
Key Exclusion Criteria:
Known current central nervous system involvement by lymphoma/leukemia
Known plasma cell neoplasm, prolymphocytic leukemia, history of or currentlysuspected 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.
Study Design
Connect with a study center
Concord Repatriation General Hospital
Concord, New South Wales 2139
AustraliaSite Not Available
St Vincent's Hospital Sydney (Kinghorn)
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Saint Vincents Hospital Sydney
Darlinghust, New South Wales 2010
AustraliaSite Not Available
Orange Health Service
Orange, New South Wales 2800
AustraliaActive - Recruiting
Orange Health Service (Central West Cancer Care Centre)
Orange, New South Wales 2800
AustraliaSite Not Available
Pindara Private Hospital
Benowa, Queensland 4217
AustraliaSite Not Available
John Flynn Private Hospital
Tugun, Queensland 4224
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaSite Not Available
Flinders Medical Centre
Bedford PK, South Australia 5042
AustraliaSite Not Available
Box Hill Hospital
Box Hill, Victoria 3128
AustraliaSite Not Available
Monash Health
Clayton, Victoria 3168
AustraliaSite Not Available
St Vincent's Hospital Melbourne
East Melbourne, Victoria 3002
AustraliaSite Not Available
St Vincents Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaSite Not Available
St. Vincent Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
Linear Clinical Research
Nedlands, Western Australia 6009
AustraliaSite Not Available
Flinders Medical Centre
Adelaide, 5042
AustraliaActive - Recruiting
Monash Health Medical Centre
Clayton, 3168
AustraliaActive - Recruiting
Peter McCallum Cancer Center (PMCC) Pharmacy
Melbourne, 3000
AustraliaActive - Recruiting
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, 01307
GermanySite Not Available
Universitätsklinikum Dresden
Dresden, 01307
GermanyActive - Recruiting
Uniklinik Koln (Aor)
Koln, 50937
GermanySite Not Available
Klinik Fur Hamatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie Und Tropenmedizin Mu
Munich, 80804
GermanySite Not Available
Universitaetsklinikum Ulm, Innere Medizin Iii
Ulm, 89081
GermanySite Not Available
Ospedale San Raffaele
Milan, 20132
ItalySite Not Available
ASST Grande Ospedale Niguarda, Niguarda Piazza Maggiore 3, Blocco Sud Ponti Est Scala 10
Milano, 20162
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalySite Not Available
Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
Ospedale San Raffaele, Servizio Farmacia Piano -2, Via Olgettina 60 Settore B
Milano, 20132
ItalyActive - Recruiting
Ospedale Santa Maria Della Misericordia
Perugia, 6132
ItalySite Not Available
Azienda Unita Sanitaria Locale Di Ravenna
Ravenna, 48121
ItalySite Not Available
Ospedale S.Maria delle Croci, Dipart. Oncologia Ematologia, Farmacia Oncol. Via le Randi 5
Ravenna, 48121
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
ItalySite Not Available
Centroricerche Cliniche Di Verona Srl
Verona, 37134
ItalySite Not Available
Auckland City Hospital,
Grafton, Auckland 1023
New ZealandSite Not Available
Inpatient Pharmacy, LG Floor , North Shore Hospital
Takapuna, Auckland 0620
New ZealandActive - Recruiting
Wellington Regional Hospital
Newtown, Wellington 0621
New ZealandSite Not Available
Auckland City Hospital
Auckland, 1023
New ZealandSite Not Available
North Shore Hospital
Takapuna, 0622
New ZealandSite Not Available
Wellington Regional Hospital (Ccdhb)
Wellington, 6021
New ZealandSite Not Available
Hospital Clinic
Barcelona, 08036
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 8036
SpainSite Not Available
Hospital St. Pau
Barcelona, 08041
SpainActive - Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025
SpainSite Not Available
Ico H Duran I Reynals
Barcelona, 08907
SpainSite Not Available
Institut Catalá Oncologia
Barcelona, 08908
SpainActive - Recruiting
Vall D Hebron Institute of Oncology Vhio
Barcelona, 08035
SpainSite Not Available
START - Fund. Jiménez Díaz
Madrid, 28040
SpainActive - Recruiting
Start Madrid Fundacion Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Clinica Universidad de Navarra Pamplona
Pamplona, 31008
SpainSite Not Available
Hospital Univ. de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
Hospital U. Marques Valdecilla
Santander, 39008
SpainActive - Recruiting
Hospital Universitario Marques de Valdecilla
Santander, 39008
SpainSite Not Available
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainSite Not Available
Cancer and Haematology Centre
Oxford, Headinton OX3 7LE
United KingdomActive - Recruiting
The Leeds Teaching Hospitals Nhs Trust
Leeds, LS9 7TF
United KingdomSite Not Available
University Hospitals of Leicester Nhs Trust Leicester Royal Infirmary
Leicester, LE1 5WW
United KingdomSite Not Available
Kings College Hospital
London, SE5 9RS
United KingdomSite Not Available
Nottingham University Hospitals Nhs Trust
Nottingham, NG51PB
United KingdomSite Not Available
Oxford University Hospitals Nhs Foundation Trust
Oxford, OX42PG
United KingdomSite Not Available
UCLA Hematologyoncology
Los Angeles, California 90095
United StatesSite Not Available
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
Stanford Health Care
Stanford, California 94305
United StatesSite Not Available
North Western University
Chicago, Illinois 60611
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
University of Kansas Medical Center Research Institute
Kansas City, Kansas 66160
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United StatesActive - Recruiting
Ann Arbor medical Center
Ann Arbor, Michigan 48109
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
University Of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
Hackensack University
Hackensack, New Jersey 07601
United StatesActive - Recruiting
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York 10065
United StatesSite Not Available
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio 43210
United StatesActive - Recruiting
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Pittsburgh Health center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Md Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.