Study on Acalabrutinib, Umbralisib, and Ublituximab for Relapsed and Untreated Chronic Lymphocytic Leukemia (CLL)

Sponsor: Jennifer R. Brown, MD, PhD

Sponsor score: 0

ClinicalTrials ID:NCT04624633

Provider View

This clinical trial is testing a combination of three drugs—acalabrutinib, umbralisib, and ublituximab—to see if they can effectively control cancer growth in patients with Chronic Lymphocytic Leukemia (CLL), whether they have been treated before or not.

Patient Parameters

Program Overview

The study aims to find out if a combination of three drugs—acalabrutinib, umbralisib, and ublituximab—can help control the growth of cancer in people with Chronic Lymphocytic Leukemia (CLL). Participants will receive these drugs for up to 24 cycles, which is about two years, and will be monitored for up to five years after stopping the treatment. The study involves about 60 participants and is a Phase II clinical trial, which means it is testing the safety and effectiveness of these drugs in treating CLL. While acalabrutinib is approved for CLL, umbralisib and ublituximab are still being studied and are not yet approved by the FDA for any disease.

Description

In this study, researchers are testing a combination of three drugs—acalabrutinib, umbralisib, and ublituximab—to see if they can effectively control cancer growth in people with Chronic Lymphocytic Leukemia (CLL). Participants will be screened for eligibility and will receive the study drugs for up to 24 cycles, which is about two years. They will be followed for up to five years after stopping the treatment to monitor their health and any long-term effects.

Acalabrutinib is a drug that blocks a protein called Bruton Tyrosine Kinase (BTK), which helps CLL cells grow. By blocking BTK, acalabrutinib may help kill cancer cells or stop them from growing. Umbralisib is an investigational drug that blocks a protein called PI3K, which also helps CLL cells grow. Ublituximab is a type of protein made in the lab that can attach to cancer cells and may help stop them from growing and spreading.

As of March 2023, the company providing umbralisib and ublituximab has decided to stop supplying these drugs and funding for the study. However, participants still on treatment will continue to have access to acalabrutinib.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
  • Must need treatment for CLL as defined by specific medical criteria.
  • Must have measurable disease, such as a high number of white blood cells or enlarged lymph nodes.
  • For Cohort 1: Must have CLL that has come back or not responded to previous treatments, with no more than two prior treatments.
  • For Cohort 2: Must have CLL that has not been treated before.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status score of 2 or less.
  • Must have adequate organ and bone marrow function based on specific blood tests.
  • Must agree to use effective contraception during the study and for four months after.
  • Must be able to understand and sign a consent form.
  • Must be able to swallow pills and take preventive medications for certain infections.

Exclusion Criteria

  • Cannot have CLL that worsened while on a BTK or PI3K inhibitor.
  • Cannot have had major surgery within 28 days before starting the study drugs.
  • Cannot be taking other investigational drugs.
  • Cannot have had a stem cell transplant recently.
  • Cannot have certain types of aggressive CLL or cancer spread to the brain.
  • Cannot have uncontrolled autoimmune diseases or bleeding disorders.
  • Cannot be on blood thinners like warfarin.
  • Cannot have had a recent stroke or heart problems.
  • Cannot have other serious health conditions that are not well-controlled.
  • Cannot have had another cancer within the last two years, with some exceptions.
  • Cannot be on certain medications that interact with the study drugs.
  • Cannot have a history of severe allergic reactions to similar drugs.
  • Cannot be pregnant or breastfeeding, and women must have a negative pregnancy test before starting the study.

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02115BostonMassachusetts

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.