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Fixed-duration pirtobrutinib plus venetoclax-rituximab versus venetoclax-rituximab for patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (BRUIN CLL-322): an open-label, multicentre, randomised, controlled, phase 3 trial.

Lancet (London, England)·2026
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Zanubrutinib, Obinutuzumab, and Venetoclax in CLL: Long-Term Follow Up, MRD Kinetics, Retreatment, T-Cell Profiling, PKs.

Blood advances·2026
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Blinatumomab and Ponatinib Versus Hyper-CVAD and Ponatinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Propensity Score Analysis.

American journal of hematology·2026
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Unfinished business in chronic lymphocytic leukemia: translational and clinical priorities for a cure.

Blood·2026
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Reply to: How to Interpret the Results in a Noninferiority Randomized Trial in Chronic Lymphocytic Leukemia.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology·2026
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Related Experiment Video

Updated: Apr 17, 2026

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Developing MRD as an early endpoint for accelerated approval in CLL.

Jacob D Soumerai1, William G Wierda2

  • 1Center for Lymphoma, Mass General Brigham Cancer Institute, Harvard Medical School, Boston, MA.

Seminars in Hematology
|April 15, 2026
PubMed
Summary

Measurable residual disease (MRD) is a strong predictor of outcomes in chronic lymphocytic leukemia (CLL). Undetectable MRD (uMRD4) may serve as an early endpoint for evaluating new fixed-duration therapies in CLL.

Keywords:
CLLChronic lymphocytic leukemiaEndpointMRDMeasurable residual disease

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Area of Science:

  • Hematology
  • Oncology
  • Clinical Trials

Background:

  • Chronic lymphocytic leukemia (CLL) treatments have improved progression-free survival (PFS), necessitating new methods to assess therapeutic efficacy.
  • Longer PFS in CLL trials may delay the evaluation of novel therapies.

Purpose of the Study:

  • To review the role of measurable residual disease (MRD) as an early endpoint in chronic lymphocytic leukemia (CLL).
  • To evaluate undetectable MRD at < 10-4 (uMRD4) as a surrogate for PFS in CLL patients on fixed-duration therapy.

Main Methods:

  • Review of Food and Drug Administration (FDA) guidance on surrogate and intermediate endpoints.
  • Description of current MRD assays used in CLL.
  • Analysis of clinical trial data on the prognostic impact of uMRD4 in CLL.

Main Results:

  • Undetectable MRD (uMRD4) is strongly linked to PFS in CLL patients receiving fixed-duration therapies.
  • The prognostic significance of uMRD4 is consistent across various treatment regimens.

Conclusions:

  • Measurable residual disease (MRD) assessment, specifically uMRD4, shows promise as an early endpoint in CLL.
  • End-of-treatment uMRD4 is being developed as an endpoint for accelerated approval of CLL therapies.