This phase Ib trial seeks to find out the best dose and possible side effects and/or benefits
of zanubrutinib in combination with the R-CHOP in treating patients with newly diagnosed
diffuse large B-cell lymphoma (DLBCL). Zanubrutinib is designed to block a protein called
Bruton Tyrosine Kinase in order to stop cancer growth. R-CHOP is the acronym for the
combination of five drugs: rituximab, cyclophosphamide, doxorubicin, vincristine and
prednisone. It is the most widely used chemoimmunotherapy regimen for DLBCL and is considered
the standard-of-care treatment for patients with DLBCL. Three of the drugs in R-CHOP
(cyclophosphamide, doxorubicin and vincristine) are chemotherapy drugs. Rituximab is a type
of immunotherapy and prednisone is a type of steroids.
I. Determine the safety, toxicity profile and recommended phase 2 dose (RP2D) of zanubrutinib
in combination with R-CHOP (ZaR-CHOP) for patients with previously untreated diffuse large
B-cell lymphoma (DLBCL).
I. Determine the objective response rate (ORR) (complete and partial responses),
progression-free survival (PFS) and overall survival (OS) of ZaR-CHOP in patients treated at
II. Provide descriptive data on treatment exposure to zanubrutinib and R-CHOP including
treatment discontinuation rate and relative dose intensity.
OUTLINE: This is a dose de-escalation study of zanubrutinib and fixed-dose R-CHOP regimen
followed by a dose-expansion study.
Patients receive zanubrutinib orally (PO) once or twice daily on days 1-21, rituximab
intravenously (IV) on day 1, cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on
day 1, vincristine sulfate IV on day 1, and prednisone PO QD on days 1-5. Treatment repeats
every 21 days for up to 6 cycles in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed every 6 months for 2 years.
Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma, Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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