Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05718869
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Tafasitamab — BIOLOGICAL
    Given IV
  • Zanubrutinib — DRUG
    Given PO

Study Details

This phase II trial tests how well tafasitamab and zanubrutinib works in treating patients with newly diagnosed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This may stop the growth and spread of cancer cells. Giving tafasitamab and zanubrutinib in combination may kill more cancer cells in patients with CLL/SLL than giving either treatment alone.

Key Dates

Start date
May 18, 2023
Status verified
May 2026
Primary completion
Sep 8, 2026
Completion
Sep 8, 2026

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (tafasitamab and zanubrutinib)
    Patients receive tafasitamab IV and zanubrutinib PO on study. Patients also undergo collection of blood samples on study and undergo CT scan and bone marrow biopsy throughout the trial.

Primary Outcome Measure

Complete response (CR) rate [ Time Frame: Up to 5 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
City of Hope at Irvine LennarIrvineCalifornia92618-
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33146-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope Medical Center· Duarte, CACity of Hope at Irvine Lennar· Irvine, CAUniversity of Miami Sylvester Comprehensive Cancer Center· Miami, FL

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