Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
N/AClinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men and women, aged 18 years or older on the day of signing the Informed Consent Form (ICF).
Histologically confirmed indolent/aggressive DLBCL, FL, MZL, or MCL.
Participants with DLBCL, MZL or MCL must have received at least 1 prior line of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
Participants with FL must have received at least 2 prior lines of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
Ineligible for stem cell transplant.
Participants with DLBCL must have failed or refused stem cell transplantation or failed first-line salvage therapy if ineligible for transplantation.
Must be willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.
Life expectancy of > 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
Adequate hematologic, hepatic, and renal function.
Willingness to avoid pregnancy or fathering a child.
Ability to comprehend and willingness to sign an ICF
Exclusion
Exclusion Criteria:**
Evidence of transformed non-Hodgkin lymphoma histologies (with the exception of FL).
Histologically confirmed rare non-Hodgkin B-cell subtypes.
History of or central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
For participants to be treated with bendamustine (Treatment B), prior treatment with bendamustine (within 12 months of the start of study treatment). Participants with prior bendamustine treatment (> 12 months before the start of study treatment) are eligible if they meet the following criteria:
Did not discontinue because of tolerability concerns.
Achieved either partial response (PR) or complete response (CR) to the bendamustine regimen of at least 12 months in duration before relapse/progression.
Experienced progression following a regimen containing an alkylating agent.
For participants to be treated with ibrutinib (Treatment C), prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor.
Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
Active graft-versus-host disease following allogeneic transplant.
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Study Design
Study Description
Connect with a study center
AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
MONZA, 20835
ItalyActive - Recruiting
OSPEDALE DELLE CROCI - EMATOLOGIA RAVENNA
RAVENNA, 48121
ItalyActive - Recruiting
Hospital General Universitari Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
HOSPITAL CLINICO UNIVERSITARIO DE SALAMANCA
Salamanca, 37007
SpainActive - Recruiting
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainActive - Recruiting
HOSPITAL UNIVERSITARI Y POLITECNIC LA FE
Valencia, Valencia 46026
SpainActive - Recruiting
UNIVERSITY OF ARIZONA CANCER CENTER - OUT PT.
TUCSON, Arizona 85719
United StatesActive - Recruiting
INDIANA BLOOD AND MARROW TRANSPLANTATION
INDIANAPOLIS, Indiana 46237
United StatesActive - Recruiting
TEXAS ONCOLOGY
Austin, Texas 78705
United StatesActive - Recruiting
Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
United StatesActive - Recruiting
BAYLOR COLLEGE OF MEDICINE
HOUSTON, Texas 77030
United StatesActive - Recruiting
SMITH CLINIC
HOUSTON, Texas 77054
United StatesActive - Recruiting
CANCER CARE CENTERS OF SOUTH TEXAS
SAN ANTONIO, Texas 78217
United StatesActive - Recruiting
Texas Oncology - San Antonio
San Antonio, Texas 78240
United StatesActive - Recruiting
HOSPITAL GERMANS TRIAS I PUJOL
BADALONA, 08916
Active - Recruiting
ASST SPEDALI CIVILI DI BRESCIA
BRESCIA, 25123
Active - Recruiting
FUNDACION JIMENEZ DIAZ UNIVERSITY HOSPITAL
MADRID, 28040
Active - Recruiting
HOSPITAL UNIVERSITARIO HM SANCHINARRO
MADRID, 28050
Active - Recruiting
AZIENDA OSPEDALIERA UNIVERSITARIA PISANA
PISA, 56126
Active - Recruiting
HOSPITAL CLINIC DE BARCELONA
BARCELONA, BARCELONA 08036
Active - Recruiting
Hospital Universitario Virgen Del Rocio
Sevilla, Sevilla 41013
Active - Recruiting
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