A Study to Evaluate Efficacy and Safety of Zanubrutinib With R-CHOP in Newly Diagnosed Non-GCB DLBCL Patients With Double Expression

Recruiting in Palo Alto (17 mi)

Overseen byJunning Cao

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Fudan University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Zanubrutinib is a highly specific, potent new Bruton's tyrosine kinase （BTK） inhibitor, with minimal off-target inhibition of other kinases. This is a single-arm, open-label Phase II study to evaluate the efficacy and safety of zanubrutinib in combination with Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in newly diagnosed non-GCB Diffuse large B-cell lymphoma (DLBCL) patients with co-expression of B-cell lymphoma 2 （BCL2）and myelocytomatosis oncogene（MYC）.

Research Team

Junning Cao

Principal Investigator

Fudan University

Eligibility Criteria

Inclusion Criteria

Histologically - confirmed non-GCB subtype.

MYC+≥40% and BCL2+≥50% by IHC

Lesions must be measurable. A measurable node lesion must have a longest diameter greater than 1.5 cm. A measurable extra-nodal lesion should have a longest diameter greater than 1.0 cm.

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Treatment Details

Interventions

Zanubrutinib (BTK Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Experimental: Zanubrutinib + R-CHOPExperimental Treatment1 Intervention

Zanubrutinib 160 mg bis in die（BID） administered by oral every day of each 21-day cycle. Rituximab 375 mg/m2, Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 (maximum total 2 mg) administered by IV infusion on Day 1 of each 21-day cycle. Prednisone 100 mg administered by oral on Day 1-5 of each 21-day cycle. After 6 cycles of zanubrutinib and R-CHOP combination therapy, patients achieved complete response （CR）will continue to receive zanubrutinib 160mg BID for 1 year.

Zanubrutinib is already approved in China for the following indications: