Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Yazeed Sawalha
Study ID
NCT04850495
Phase
PHASE1
Status
Suspended

Conditions

  • Diffuse Large B-Cell Lymphoma
  • Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
  • Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine Sulfate — DRUG
    Given IV
  • Zanubrutinib — DRUG
    Given PO

Study Details

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-PolaCHP 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.

Key Dates

Start date
Nov 16, 2021
Status verified
Jun 2026
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (zanubrutinib, R-CHOP)
    Patients receive zanubrutinib PO on days 1-21, rituximab 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 toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 24 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
MUSCCharlestonSouth Carolina29425-

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic· Cleveland, OHOhio State University Comprehensive Cancer Center· Columbus, OHMUSC· Charleston, SC

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