TriangleHEALTH PROFESSIONAL · SOURCE READING
Treatment for Patients With Highest-Risk Disease
Source: Mantle Cell Lymphoma Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 12, 2025 · Captured 2026-09-09.
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Context: Treatment of Relapsed/Refractory Mantle Cell Lymphoma
Evidence (treatment for patients with highest-risk disease with blastoid morphology, Ki-67 ≥30%, a TP53 pathogenic variant, or progression of disease <2 years after initial therapy):
A prospective randomized trial of patients with relapsed or refractory MCL compared ibrutinib plus venetoclax (the BCL-2 inhibitor) versus ibrutinib alone. TP53 pathogenic variants were present in 49% of patients.[18]
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A prospective randomized trial of patients with relapsed or refractory MCL compared ibrutinib plus venetoclax (the BCL-2 inhibitor) versus ibrutinib alone. TP53 pathogenic variants were present in 49% of patients.[18]
With a median follow-up of 51.2 months, the PFS favored the ibrutinib combination compared with ibrutinib alone (31.9 months vs. 22.1 months; HR, 0.65; 95% CI, 0.47–0.88; P = .0052). This benefit was seen for the patients with blastoid morphology or TP53 pathogenic variants.[18][Level of evidence B1]
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A prospective randomized trial of patients with relapsed or refractory MCL compared ibrutinib plus venetoclax (the BCL-2 inhibitor) versus ibrutinib alone. TP53 pathogenic variants were present in 49% of patients.[18]
The complete response rate was 54% in the combination group and 32% in the ibrutinib-alone group (P = .004).[18][Level of evidence C3]
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A prospective randomized trial of patients with relapsed or refractory MCL compared ibrutinib plus venetoclax (the BCL-2 inhibitor) versus ibrutinib alone. TP53 pathogenic variants were present in 49% of patients.[18]
The median OS was 44.9 months for the ibrutinib-plus-venetoclax arm and 38.6 months for the ibrutinib-alone arm, but this was not statistically significant (P = .346).
A prospective randomized trial of patients with relapsed or refractory MCL compared ibrutinib plus venetoclax (the BCL-2 inhibitor) versus ibrutinib alone. TP53 pathogenic variants were present in 49% of patients.[18]
The triple combination of obinutuzumab, ibrutinib, and venetoclax is being studied in clinical trials for the highest-risk patients with relapsed or refractory MCL.
Publication references
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Preserved source evidence · Not medical advice