A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants with Previously Treated Indolent Non-Hodgkin Lymphoma

Phase 1

• Conditions: Indolent Non-Hodgkin Lymphoma (iNHL); MedDRA version: 20.0 Level: HLT Classification code 10029621 Term: Non-Hodgkin's lymphomas unspecified histology indolent System Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003093-27-GB
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-28
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

- Histologically confirmed diagnosis of B-cell indolent Non-Hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma, at initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation
- At least 1 prior treatment with a CD20 antibody combination chemo-immunotherapy regimen
- Disease that has relapsed or was refractory after prior chemo-immunotherapy
- At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma 2007
- Eastern Cooperative Oncology Group performance status grade 0 or 1
- Laboratory values within protocol-defined parameters
- Agrees to protocol-defined use of effective contraception
- Men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, whichever is later
- Women of childbearing potential must have a negative serum or urine
pregnancy test at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

-Prior treatment according to protocol-defined criteria
-Unable to receive background chemotherapy based on prior treatment history and cardiac function
-Known central nervous system lymphoma
-Diagnosed or treated for malignancy other than indolent Non-Hodgkin lymphoma
-History of stroke or intracranial hemorrhage within 6 months prior to
randomization
-Requires anticoagulation with warfarin or equivalent Vitamin K antagonists
-Requires treatment with strong CYP3A inhibitors
-Clinically significant cardiovascular disease
-Known history of human immunodeficiency virus or active hepatitis C virus (HCV; ribonucleic acid [RNA] polymerase chain reaction [PCR]-positive) or active hepatitis B virus (HBV; DNA PCR-positive) infection or any uncontrolled active systemic infection regarding intravenous antibiotics
-Any 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 ibrutinib capsules, or put the study outcomes at undue risk
-Women who are pregnant or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified