NCT01569750

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

Completed Phase 1 Last updated 22 August 2017

What this trial tests

Phase 1 trial testing Part 1, Cohort 1 in CD20-positive B-cell Non-Hodgkin Lymphoma in 33 participants. Completed in 4 September 2014.

Timeline

14 June 2012

Primary endpoint
4 September 2014

4 September 2014

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	14 June 2012
Primary completion	4 September 2014
Estimated completion	4 September 2014
Sites	7 locations across France, United States

Drugs / interventions tested

• Part 1, Cohort 1
• Part 1, Cohort 2
• Part 1, Cohort 3
• Part 2, Cohort 1
• Part 2, Cohort 2

Conditions studied

• CD20-positive B-cell Non-Hodgkin Lymphoma — all drugs for CD20-positive B-cell Non-Hodgkin Lymphoma →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with CD20-positive B-cell Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic antitumor immunity by checkpoint blockade is enhanced by ibrutinib, an inhibitor of both BTK and ITK.
   Sagiv-Barfi I, Kohrt HE, Czerwinski DK, Ng PP, et al · · 2015 · cited 344× · PMID 25730880 · DOI 10.1073/pnas.1500712112
2. 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.
   Younes A, Thieblemont C, Morschhauser F, Flinn I, et al · · 2014 · cited 194× · PMID 25042202 · DOI 10.1016/s1470-2045(14)70311-0
3. Ibrutinib and novel BTK inhibitors in clinical development.
   Akinleye A, Chen Y, Mukhi N, Song Y, et al · · 2013 · cited 176× · PMID 23958373 · DOI 10.1186/1756-8722-6-59
4. Advances in targeted therapy for malignant lymphoma.
   Wang L, Qin W, Huo YJ, Li X, et al · · 2020 · cited 88× · PMID 32296035 · DOI 10.1038/s41392-020-0113-2
5. Novel Bruton's tyrosine kinase inhibitors currently in development.
   D'Cruz OJ, Uckun FM. · · 2013 · cited 25× · PMID 23493945 · DOI 10.2147/ott.s33732
6. Mechanistic physiology-based pharmacokinetic modeling to elucidate vincristine-induced peripheral neuropathy following treatment with novel kinase inhibitors.
   Pilla Reddy V, Fretland AJ, Zhou D, Sharma S, et al · · 2021 · cited 6× · PMID 34080039 · DOI 10.1007/s00280-021-04302-5
7. Activity of ibrutinib plus R-CHOP in diffuse large B-cell lymphoma: Response, pharmacodynamic, and biomarker analyses of a phase Ib study.
   Schaffer M, Chaturvedi S, Davis C, de Jong J, et al · · 2020 · cited 3× · PMID 33188997 · DOI 10.1016/j.ctarc.2020.100235
8. Walking a tightrope: clinical use of ibrutinib in mantle cell lymphoma in the elderly.
   Ruella M, Soubeyran P. · · 2016 · cited 1× · PMID 27913512 · DOI 10.1182/asheducation-2016.1.432