Study on Acalabrutinib with DA-EPOCH-R or R-CHOP for Untreated Diffuse Large B-cell Lymphoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04002947

Provider View

This clinical trial is testing whether adding the drug acalabrutinib to standard chemotherapy treatments can improve cure rates for people with untreated aggressive B-cell lymphomas, such as diffuse large B-cell lymphoma.

Patient Parameters

Program Overview

Diffuse large B-cell lymphoma is a common type of non-Hodgkin lymphoma. While many people can be cured, those who aren't have a poor outlook. This study aims to see if adding acalabrutinib to standard treatments like rituximab and chemotherapy can improve cure rates for aggressive B-cell lymphomas. Participants will undergo various tests and take acalabrutinib for up to 14 days, followed by chemotherapy and possibly more acalabrutinib. The study includes up to 6 treatment cycles, with follow-up visits for several years.

Description

This study focuses on improving treatment for diffuse large B-cell lymphoma (DLBCL), a type of aggressive B-cell lymphoma. Researchers are exploring whether adding acalabrutinib, a drug that targets specific cancer cell pathways, to standard chemotherapy can enhance treatment outcomes.

Participants will first take acalabrutinib alone for 14 days. Depending on their response, they will then receive either standard chemotherapy alone or in combination with acalabrutinib. The chemotherapy regimens used are R-CHOP or DA-EPOCH-R, which are standard treatments for DLBCL.

The study will monitor how well the cancer responds to the treatment, as well as the safety and tolerability of the drug combination. Participants will undergo regular tests, including blood and urine tests, imaging scans, and possibly biopsies, to track their progress.

The trial is open to adults aged 18 and older who have not received prior treatment for their lymphoma. Participants will be followed for several years to assess long-term outcomes, including survival rates and any side effects from the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of aggressive B-cell lymphoma, such as DLBCL or high-grade B-cell lymphoma, with no prior treatment.
  • Must have measurable lymph nodes or masses of at least 1.5 cm on scans.
  • Must be in stage II, III, or IV of the disease.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have adequate organ and bone marrow function, with specific blood counts and organ function levels.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a specified period after.
  • Men must agree to use effective contraception during the study and for a specified period after.
  • Must be able to understand and sign a consent form.
  • HIV status must be confirmed before enrollment.

Exclusion Criteria

  • Cannot have certain subtypes of lymphoma, such as primary DLBCL of the central nervous system or primary mediastinal B-cell lymphoma.
  • Cannot need immediate chemotherapy due to severe symptoms or organ compromise.
  • Cannot have received any prior treatment for DLBCL.
  • Cannot have had major surgery within 30 days before starting the study drug.
  • Cannot require certain medications that interact with the study drug.
  • Cannot have cancer that has spread to the central nervous system.
  • Cannot be pregnant or breastfeeding.
  • Cannot have uncontrolled illnesses that could interfere with the study, such as active infections or significant heart disease.
  • Cannot be participating in another clinical trial.

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