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Richter SyndromeGeneticsProcedureDrugBiologicalPhase 3

What this study is

This phase III trial compares the effect of adding pirtobrutinib to the usual treatment with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) to R-CHOP alone for the treatment of Richter transformation, which is when chronic lymphocytic leukemia or small lymphocytic lymphoma turns into large B-cell lymphoma, a more aggressive (faster-growing) form of lymphoma. Pirtobrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Adding pirtobrutinib to R-CHOP may kill more cancer cells than R-CHOP alone in patients with Richter transformation.

What's being tested

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood and buccal swab sample collection

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT scan and/or PET/CT scan

  • Cyclophosphamide

    Intervention · DRUG

  • Doxorubicin Hydrochloride

    Intervention · DRUG

  • Echocardiography Test

    Intervention · PROCEDURE

    Undergo echocardiography

  • Multigated Acquisition Scan

    Intervention · PROCEDURE

    Undergo MUGA scan

  • Pirtobrutinib

    Intervention · DRUG

  • Positron Emission Tomography

    Intervention · PROCEDURE

    Undergo PET/CT scan

  • Prednisone

    Intervention · DRUG

  • Rituximab

    Intervention · BIOLOGICAL

  • Rituximab and Hyaluronidase Human

    Intervention · BIOLOGICAL

    Given SC

  • Survey Administration

    Intervention · OTHER

    Ancillary studies

  • Vincristine

    Intervention · DRUG

All of Cyclophosphamide, Doxorubicin Hydrochloride, Rituximab, Vincristine

Given IV

Both Pirtobrutinib and Prednisone

Given PO

Study details

Official title
A Randomized Phase III Study of Pirtobrutinib Plus R-CHOP vs. R-CHOP for Participants With Previously Untreated Richter Transformation (PIRAMID)
Sponsor
SWOG Cancer Research Network
Conditions
Richter Syndrome · Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma · Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma
Enrolling
102 people
Starts
2026-08-04
Est. completion
2036-10
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗