Clinical trial · Interventional
A Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With CD20-Positive B-Cell Non Hodgkin Lymphoma
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)
NCT01569750CI-TRIAL-00029194completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD20-positive B-cell Non-Hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Part 1, Cohort 1 | Drug | — | UNRESOLVED |
| Part 1, Cohort 2 | Drug | — | UNRESOLVED |
| Part 1, Cohort 3 | Drug | — | UNRESOLVED |
| Part 2, Cohort 1 | Drug | — | UNRESOLVED |
| Part 2, Cohort 2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ibrutinib
- description
- 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.
- interventionNames
- Drug: Part 1, Cohort 1
- Drug: Part 1, Cohort 2
- Drug: Part 1, Cohort 3
- Drug: Part 2, Cohort 1
- Drug: Part 2, Cohort 2
Primary outcomes (1)
- measure
- Part 1 maximum tolerated dose of ibrutinib
- timeFrame
- Up to Cycle 1, Day 21 in Part 1
- description
- The Part 1 maximum tolerated dose (MTD) is the Part 2 recommended ibrutinib dose.
Secondary outcomes (15)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically-confirmed CD20-positive B-cell non Hodgkin lymphoma disease for whom R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) is an appropriate therapy (diffuse large B-cell lymphoma, mantle cell lymphoma, or follicular lymphoma); for the expansion cohort, at least 1 cohort will only include patients with newly diagnosed diffuse large B-cell lymphoma * Stage I AX (bulk defined as single lymph node mass \>=10 cm in diameter) to Stage IV disease * At least 1 measurable site of disease based on the Revised Response Criteria for Malignant Lymphoma * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 * Adequate bone marrow, liver, and renal function Exclusion Criteria: * History of protocol-defined disallowed therapies * Prior multidrug chemotherapy treatment for lymphoma * History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug * Major surgery within 3 weeks before enrollment * Known bleeding diatheses, platelet dysfunction disorders, or requires therapeutic anticoagulation * Known lymphoma of the central nervous system * Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, pericardial disease, cardiac amyloidosis, clinically significant cardiac arrhythmia, or left ventricular ejection fraction outside of institutional limits * Active systemic infection requiring treatment including hepatitis B and hepatitis C infection * Documented or suspected human immunodeficiency virus infection * Diagnosed or treated for a malignancy other than non-Hodgkin lymphoma except; adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ of the breast, or other solid tumors curatively treated with no evidence of disease for \>5 years * Has any condition that, in the opinion of the investigator, would make study participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
References
Publications (1)
- DERIVEDYounes 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. PMID 25042202