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Clinical Trial
. 2024 Nov 12;8(21):5674-5682.
doi: 10.1182/bloodadvances.2024014035.

Ibrutinib plus rituximab and mini-CHOP in older patients with newly diagnosed DLBCL: a phase 2 ALLG study

Emma Verner  1   2 , Amanda Johnston  2   3 , Nalini Pati  4   5 , Eliza A Hawkes  6   7   8 , Hui-Peng Lee  9 , Tara Cochrane  10   11 , Chan Yoon Cheah  12   13   14 , Robin Filshie  15   16 , Duncan Purtill  13   17 , Hanlon Sia  18 , Anoop K Enjeti  19   20 , Christina Brown  2   21 , Nicholas Murphy  22 , Jennifer Curnow  2   3 , Kenneth Lee  1   2 , Maher K Gandhi  23 , Mannu Walia  24 , Belinda E Butcher  25   26 , Judith Trotman  1   2
Affiliations
Clinical Trial

Ibrutinib plus rituximab and mini-CHOP in older patients with newly diagnosed DLBCL: a phase 2 ALLG study

Emma Verner et al. Blood Adv. .

Abstract

The multicenter, prospective phase 2 Australasian Leukaemia & Lymphoma Group NHL29 trial was conducted to assess the addition of ibrutinib to R-mini-CHOP (dose attenuated R-CHOP; rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients aged ≥75 years with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Treatment consisted of six 21-day cycles of ibrutinib-R-mini-CHOP followed by two 21-day cycles of R-ibrutinib. Coprimary end points were deliverability and 2-year overall survival (OS). The median average relative total dose and average relative dose intensity for the entire regimen were both 97% (interquartile range, 82-100 and 88-100, respectively). With a median follow-up of 35.5 months, the 2-year OS was 68% (95% confidence interval [CI], 55.6-77.4) with a 2-year progression-free survival (PFS) of 60.0% (95% CI, 47.7-70.3). Median OS and PFS were 72 months (95% CI, 35 to not reached) and 40 months (95% CI, 20.4 to not reached), respectively. The overall response rate was 76% (61/79) of patients, with a complete response rate of 71% (56/79). Deaths occurred in 34 of 79 patients (43%), including 17 from progressive disease and 5 treatment related. Overall, 67% patients experienced at least 1 serious adverse event. Most common adverse events were infections and diarrhea (the majority grade 1-2). In both health-related quality of life measures, there was an improvement in functional and symptom scales, median health state classification score, and median visual analogue scale in responders over time. In conclusion, this study showed that the addition of ibrutinib to R-mini-CHOP was both deliverable and efficacious in elderly DLBCL patients.

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Conflict of interest statement

Conflict-of-interest disclosure: E.V. has received research funding paid to her institution for clinical trials from Janssen, BeiGene, AbbVie, Loxo Oncology, and Roche; and reports a role in an advisory board for BeiGene. J.T. has received research funding paid to her institution for clinical trials from Roche, Bristol Myers Squibb, BeiGene, Cellectar, Pharmacyclics and Janssen. T.C. has received research funding from BeiGene. E.A.H. has received research funding paid to her institution from Bristol Myers Squibb, Merck KgaA, AstraZeneca, Roche, and TG Therapeutics; reports a role in an advisory board for Roche, Antengene, Bristol Myers Squibb, Gilead, AstraZeneca, and Regeneron; and serves on a speakers bureau for Regeneron, Janssen, and AstraZeneca. C.Y.C. consults for, serves on advisory boards of, and receives honoraria from Roche, Janssen, Gilead, AstraZeneca, Eli Lilly, BeiGene, Menarini, Dizal, AbbVie, Genmab, and Bristol Myers Squibb; and reports research funding from Bristol Myers Squibb, Roche, AbbVie, Merck Sharp & Dohme, and Eli Lilly. M.K.G. receives study drug from Janssen for a clinical trial. B.E.B. is an independent statistician who consults to a wide variety of pharmaceutical and device companies. The remaining authors declare no competing financial interests.

A complete list of the members of the Australasian Leukaemia & Lymphoma Group involved in this study appears in “Appendix.”

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Disposition diagram.
Figure 2.
Figure 2.
Overall Survival & Progression Free Survival (A) Kaplan-Meyer OS; (B) Kaplan-Meyer PFS.
Figure 3.
Figure 3.
Most common AEs.
Figure 4.
Figure 4.
Quality-of-life graphs. (A) Functioning scales; (B) Symptom scales.
See this image and copyright information in PMC

References

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