A Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With CD20-Positive B-Cell Non Hodgkin Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

June 14, 2012

Primary Completion Date

September 4, 2014

Study Completion Date

September 4, 2014

Conditions
CD20-positive B-cell Non-Hodgkin Lymphoma
Interventions
DRUG

Part 1, Cohort 1

Type=exact number, unit=mg, number=280, form=capsule, route=oral use. Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.

DRUG

Part 1, Cohort 2

Type=exact number, unit=mg, number=420, form=capsule, route=oral use. Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.

DRUG

Part 1, Cohort 3

Type=exact number, unit=mg, number=560, form=capsule, route=oral use. Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.

DRUG

Part 2, Cohort 1

Ibrutinib at the recommended Part 1 dose administered once daily with standard-of-care doses of R-CHOP in patients with newly diagnosed diffuse large B-cell lymphoma.

DRUG

Part 2, Cohort 2

Ibrutinib at the recommended Part 1 dose administered once daily with standard-of-care doses of R-CHOP in patients with newly diagnosed with B-cell non-Hodgkin lymphoma.

Trial Locations (7)

Unknown

New York

Rochester

Nashville

Houston

Lille

Paris

Vandœuvre-lès-Nancy

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY