Study on Acalabrutinib, Venetoclax, and Obinutuzumab for Relapsed/Refractory and Untreated Mantle Cell Lymphoma

Sponsor: Austin I Kim

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04855695

Provider View

This clinical trial is exploring a combination of three drugs—acalabrutinib, venetoclax, and obinutuzumab—as a potential treatment for patients with mantle cell lymphoma (MCL) that has either returned after treatment or has not been treated before.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a combination of three drugs—acalabrutinib, venetoclax, and obinutuzumab (AVO)—in treating mantle cell lymphoma (MCL) that has either come back after treatment or has not been treated before. Participants will receive these drugs as long as they do not experience serious side effects and their disease does not worsen. The study will follow participants for up to 5 years, and about 53 people are expected to join. This is a Phase I/II trial, which means it is testing the safety and appropriate dosage of these drugs for future studies. While acalabrutinib is approved for this disease, venetoclax and obinutuzumab are not yet approved for MCL but are approved for other uses.

Description

This study is open-label, meaning both the researchers and participants know which treatment is being given. It is a single-arm study, so all participants receive the same treatment. The study involves screening for eligibility, receiving the study treatment, and attending follow-up visits. Participants will continue treatment as long as there are no serious side effects and the disease does not progress. The study will last for up to 5 years, with 53 participants expected to take part. The trial is in Phase I/II, focusing on the safety and dosage of the drugs. Acalabrutinib is approved for MCL, but venetoclax and obinutuzumab are not yet approved for this specific disease.

Eligibility Criteria

Inclusion Criteria

  • Must have mantle cell lymphoma confirmed by a lab test.
  • For those whose cancer has returned or not responded to previous treatment, they must have had at least one prior therapy including an anti-CD20 antibody.
  • For those who have not had previous treatment, they must need treatment due to symptoms or organ function issues caused by the cancer.
  • Must be 18 years or older.
  • Must have good overall health with a performance status score of 0 to 2.
  • Must have adequate organ and bone marrow function as shown by specific blood tests.
  • Women of childbearing potential must agree to use effective contraception during and after treatment.
  • Must be willing to provide blood and bone marrow samples for research purposes.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have had previous treatment with BTK or BCL2 inhibitors.
  • Cannot be taking other investigational drugs or have taken them recently.
  • Cannot be on systemic immunosuppressant therapy or high-dose steroids.
  • Cannot have severe allergies to similar drugs.
  • Cannot have other active cancers, except for certain low-risk types.
  • Cannot have brain or spinal cord cancer spread.
  • Cannot have had major surgery recently or need major surgery during the study.
  • Cannot have received live vaccines recently.
  • Cannot have active HIV, hepatitis B, or hepatitis C infections.
  • Cannot have uncontrolled infections or serious health conditions.
  • Cannot be pregnant or breastfeeding.
  • Cannot have bleeding disorders or recent gastrointestinal bleeding.
  • Cannot have had recent strokes or heart issues.
  • Cannot be on certain medications that interact with the study drugs.
  • Must be able to swallow pills and not have severe digestive issues.

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