Study on Acalabrutinib, Umbralisib, and Ublituximab for Treating Untreated Mantle Cell Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT04783415

Provider View

This clinical trial is exploring a new combination of drugs—acalabrutinib, umbralisib, and ublituximab—to treat patients with mantle cell lymphoma who have not received any prior treatment. The study aims to see if these drugs can effectively stop cancer growth and improve patient outcomes.

Patient Parameters

Program Overview

This study is testing a combination of three drugs—acalabrutinib, umbralisib, and ublituximab—to treat mantle cell lymphoma, a type of cancer that affects the lymph nodes. These drugs work by blocking certain enzymes and proteins that cancer cells need to grow and spread. The goal is to see if this combination can better control the disease in patients who have not been treated before.

Description

The main goal of this study is to see how well the combination of acalabrutinib, umbralisib, and ublituximab (AU2) works in shrinking tumors in patients with untreated mantle cell lymphoma. Researchers will also look at how long patients live without the disease getting worse and how long the treatment effects last. They will monitor the safety and side effects of the treatment.

Patients will first receive an induction phase of treatment, where they get ublituximab through an IV on specific days, along with acalabrutinib and umbralisib taken by mouth daily for 6 cycles of 28 days each. If the disease does not progress and side effects are manageable, patients will continue with a maintenance phase, receiving the same drugs for up to 24 more cycles.

After finishing the treatment, patients will have follow-up visits for 30 days and then every 6 months for 2 years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Have a confirmed diagnosis of mantle cell lymphoma with specific genetic markers.
  • Be 65 years or older, or 50 years and older if not eligible for aggressive treatment, or 18 years and older with certain genetic mutations.
  • Need treatment for mantle cell lymphoma and have not received prior systemic cancer treatments.
  • Have measurable disease by scans or bone marrow involvement.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a specified time after.
  • Men and women must agree to use birth control or abstain from sex during the study and for a specified time after.

Exclusion Criteria

  • Chronic use of high-dose steroids.
  • Recent major surgery without full recovery.
  • Allergies to study drugs.
  • Participation in another clinical trial.
  • History of other cancers unless treated and inactive for 2 years.
  • Uncontrolled autoimmune conditions.
  • Need for certain medications that interfere with the study drugs.
  • Gastrointestinal issues affecting drug absorption.
  • Recent gastrointestinal ulcers.
  • Bleeding disorders.
  • Recent significant heart or brain events.
  • Active central nervous system involvement by lymphoma.
  • Severe heart disease.
  • Inability to swallow pills.
  • Active infections requiring treatment.
  • Recent live vaccines.
  • Active hepatitis B, C, or CMV infections.
  • HIV infection.
  • Pregnant or breastfeeding women.
  • Any condition that may interfere with study participation.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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