Study on Acalabrutinib and Obinutuzumab for Treating Untreated Follicular Lymphoma or Other Slow-Growing Non-Hodgkin Lymphomas

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04883437

Provider View

This clinical trial is exploring the effects of combining acalabrutinib and obinutuzumab to treat patients with follicular lymphoma or other slow-growing types of non-Hodgkin lymphoma who have not received any previous treatment.

Patient Parameters

Program Overview

This study is testing whether the combination of acalabrutinib and obinutuzumab can effectively treat patients with follicular lymphoma or other slow-growing non-Hodgkin lymphomas who have not been treated before. Acalabrutinib may help stop cancer cells from growing by blocking certain enzymes, while obinutuzumab may help the immune system fight cancer cells. Together, these drugs may kill more cancer cells.

Description

The main goal of this study is to see if acalabrutinib and obinutuzumab can effectively treat patients with untreated, low tumor burden follicular lymphoma and other slow-growing non-Hodgkin lymphomas. Researchers will also look at how well patients tolerate the treatment and how it affects their quality of life.

During the study, patients will first receive acalabrutinib alone to see how it works on its own. Then, they will receive both acalabrutinib and obinutuzumab together. The treatment will be given in cycles, with each cycle lasting 28 days, for up to 12 cycles.

After 12 cycles, patients who have no signs of cancer may either stop taking acalabrutinib or continue with it alone, depending on their doctor's advice. Patients whose cancer has shrunk or stayed the same will continue with acalabrutinib alone. If the cancer grows, the treatment will be stopped.

Patients will be monitored regularly after the treatment to check their health and see how long they remain free of cancer or need further treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Have not received any previous treatment for follicular lymphoma or other slow-growing non-Hodgkin lymphomas.
  • Have a low tumor burden or are unable/unwilling to receive standard treatments.
  • Have at least one lymph node or disease site that can be measured.
  • Have a good overall health status (ECOG score of 0-2).
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting treatment.
  • Willing to participate in all study procedures and provide informed consent.

Exclusion Criteria

  • Have a history of aggressive or high-grade non-Hodgkin lymphoma.
  • Have active or past central nervous system disease.
  • Have received any previous lymphoma treatment or antibody-based therapy.
  • Have another active cancer or a history of cancer that could affect survival.
  • Have significant heart disease or recent heart problems.
  • Have difficulty swallowing pills or have severe digestive issues.
  • Have active infections or a history of severe allergic reactions to study drugs.
  • Have bleeding disorders or uncontrolled autoimmune conditions.
  • Are pregnant or breastfeeding.
  • Are participating in another clinical trial.

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