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Clinical practice recommendations on the role of allogeneic hematopoietic cell transplantation and chimeric antigen receptor T-cell therapy in patients with chronic lymphocytic leukemia on behalf of the American Society for Transplantation and Cellular Therapy

Mohamed A Kharfan-Dabaja1, Ambuj Kumar2, Javier Pinilla-Ibarz3

  • 1Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Jacksonville, FL, USA.

Transplantation and Cellular Therapy
|June 13, 2025

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  • Biomedical And Clinical Sciences
  • Oncology And Carcinogenesis
  • Cancer Therapy (excl. Chemotherapy And Radiation Therapy)
  • Clinical Practice Recommendations On The Role Of Allogeneic Hematopoietic Cell Transplantation And Chimeric Antigen Receptor T-cell Therapy In Patients With Chronic Lymphocytic Leukemia On Behalf Of The American Society For Transplantation And Cellular Therapy

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    View abstract on PubMed

    Summary
    This summary is machine-generated.

    Chimeric antigen receptor T-cell (CAR T-cell) therapy is now recommended for relapsed or refractory chronic lymphocytic leukemia (CLL) after specific targeted therapies or allogeneic stem cell transplant. Updated guidelines address CAR T-cell and allo-HCT roles in R/R CLL management.

    Area of Science:

    • Hematology
    • Oncology
    • Immunotherapy

    Background:

    • Chronic lymphocytic leukemia (CLL) treatment has evolved beyond chemoimmunotherapy (CIT).
    • Novel agents like Bruton's tyrosine kinase (BTK) inhibitors and BCL-2 inhibitors (venetoclax) are now standard front-line and relapsed/refractory (R/R) therapies.
    • Allogeneic hematopoietic cell transplantation (allo-HCT) is now a later-stage treatment option for R/R CLL.

    Purpose of the Study:

    • To update clinical practice recommendations for allo-HCT in CLL.
    • To provide guidance on the contemporary use of CAR T-cell therapy and allo-HCT in R/R CLL.
    • To reflect the impact of novel therapies on treatment algorithms.

    Main Methods:

    • A panel of 18 physicians with expertise in CLL treatment modalities convened.
    Keywords:
    Allogeneic hematopoietic cell transplantationChimeric antigen receptor T-cell therapyChronic lymphocytic leukemiaRelapsed and/or refractory disease

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  • Consensus was defined as recommendations receiving ≥ 70% of votes.
  • Expert opinion and consensus-building process informed the updated guidelines.

    • Main Results:

    • CAR T-cell therapy is recommended for R/R CLL after 2 lines including a covalent BTK inhibitor and BCL-2 inhibitor.
    • CAR T-cell therapy is also recommended for R/R CLL after a non-covalent BTK inhibitor (3rd-line+) or post-allo-HCT.
    • Allo-HCT is recommended for CAR T-cell refractory CLL (with response pre-transplant) and for Richter transformation (RT) post-front-line therapy or R/R RT.

    Conclusions:

    • Updated recommendations position CAR T-cell therapy and allo-HCT strategically in R/R CLL management.
    • These therapies are recommended in specific scenarios, including post-targeted therapy failure and post-allo-HCT relapse.
    • Enrollment in clinical trials is crucial for advancing R/R CLL treatment and improving patient outcomes.