A Phase 1b Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With CD20-Positive B-Cell Non Hodgkin Lymphoma (NHL)
Sponsor study identifier
Secondary identifiers
OTHER · Janssen Research & Development, LLC
EUDRACT_NUMBER
interventional
33
2 countries
7
Study Start
June 14, 2012
Actual (reported)Primary Completion
September 4, 2014
Actual (reported)Study Completion
September 4, 2014
Actual (reported)The purpose of this study is to identify if, and at what dose, ibrutinib may be administered with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and to document responses of this combination in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 4, 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 30, 2012
Actual (reported)April 3, 2012
Actual (reported)June 14, 2012
Actual (reported)September 4, 2014
Actual (reported)September 4, 2014
Actual (reported)Part 1 maximum tolerated dose of ibrutinib
The Part 1 maximum tolerated dose (MTD) is the Part 2 recommended ibrutinib dose.
Up to Cycle 1, Day 21 in Part 1
The number of participants affected by a dose-limiting toxicity
Up to Cycle 6, Day 21 in Part 1
Number of participants with potential drug-drug interactions between ibrutinib and vincristine
Up to Cycle 6, Day 21 in Part 2
Part 1 (Dose Escalation): 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 (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) until maximum tolerated dose is achieved. Part 2: Ibrutinib at the recommended Part 1 dose administered once daily with standard-of-care doses of R-CHOP.
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.
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.
New York, New York, United States
Rochester, New York, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Lille, France
Paris, France
Vandœuvre-lès-Nancy, France
Younes A, Thieblemont C, Morschhauser F, Flinn I, Friedberg JW, Amorim S, Hivert B, Westin J, Vermeulen J, Bandyopadhyay N, de Vries R, Balasubramanian S, Hellemans P, Smit JW, Fourneau N, Oki Y. Combination of ibrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for treatment-naive patients with CD20-positive B-cell non-Hodgkin lymphoma: a non-randomised, phase 1b study. Lancet Oncol. 2014 Aug;15(9):1019-26. doi: 10.1016/S1470-2045(14)70311-0. Epub 2014 Jul 17.
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
33 participants (actual enrollment reported by the registry).
First Submitted
March 30, 2012
First Posted
April 3, 2012
Study Start
June 14, 2012
Actual (reported)Primary Completion
Overall response rate
Up to Cycle 6, Day 21 in Part 2
Duration of response
Up to Cycle 6, Day 21 in Part 2
Progression-free survival
Up to Cycle 6, Day 21 in Part 2
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
September 4, 2014
Actual (reported)Study Completion
September 4, 2014
Actual (reported)Last Updated
August 22, 2017
Record last verified: 2017-08
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