RecruitingPhase 1NCT05943496

Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

A Phase Ib Study Evaluating the Safety and Efficacy of Tafasitamab, Acalabrutinib, and Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma


Sponsor

OHSU Knight Cancer Institute

Enrollment

27 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib trial tests the safety and effectiveness of tafasitamab, acalabrutinib, and obinutuzumab in treating patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). CLL and SLL are types of cancer that develops from a specific white blood cell called B cells or B lymphocytes. Tafasitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell cancers such as CLL at abnormal levels. This may help keep cancer cells from growing and spreading. Giving tafasitamab, acalabrutinib, and obinutuzumab may kill more cancer cells in patients with previously untreated CLL and SLL.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three targeted therapies — tafasitamab, acalabrutinib, and obinutuzumab — for people who have never been treated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are slow-growing blood cancers, and this drug combination aims to improve treatment without traditional chemotherapy. **You may be eligible if...** - You are 18 or older and have been newly diagnosed with CLL or SLL (never treated before) - Your diagnosis has been confirmed by blood tests or a lymph node biopsy - You meet the standard criteria indicating treatment is needed (e.g., worsening blood counts, enlarged lymph nodes) - You are able to swallow oral medications **You may NOT be eligible if...** - You have already received treatment for CLL or SLL - You have certain heart rhythm problems or other conditions that make these drugs unsafe - You have active, uncontrolled infections - Your organ function does not meet the required levels for safe treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

Given PO

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow biopsy and/or aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and/or aspiration

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREEchocardiography

Undergo ECHO

BIOLOGICALObinutuzumab

Given IV

OTHERQuestionnaire Administration

Ancillary studies

BIOLOGICALTafasitamab

Given IV


Locations(1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

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NCT05943496


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