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Recently, the Journal of Clinical Oncology published the results of a phase II study IMCL-2015 from Spain , which mainly evaluated the use of Ibrutinib (ibrutinib) in combination with Rituximab in patients with clinically indolent mantle cell lymphoma (MCL).
(Rituximab) treatment efficacy
.
(Rituximab) treatment efficacy
.
lymphoma
The IMCL-2015 study (NCT02682641) is a multicenter, single-arm, open-label, phase II study conducted at 12 centers in Spain
.
The primary endpoint was the complete response (CR) rate achieved after 12 cycles according to Lugano criteria
The IMCL-2015 study (NCT02682641) is a multicenter, single-arm, open-label, phase II study conducted at 12 centers in Spain
The study included 50 patients with MCL (66% male; mean age 65 years)
Efficacy assessment
Efficacy assessmentAfter a median follow-up of 36 months, the 36-month progression-free survival (PFS) rate was 93% (95% CI, 86 - 100), with only MIPI and TP53 mutational status having a significant effect on PFS, in molecular subtypes ( nnMCL vs cMCL) and genome complexity
.
.
After a median follow-up of 36 months, the 36-month progression-free survival (PFS) rate was 93% (95% CI, 86 - 100), with only MIPI and TP53 mutational status having a significant effect on PFS, in molecular subtypes ( nnMCL vs cMCL) and genome complexity
prognostic analysis
prognostic analysisThe median PFS of patients with TP53 mutation was 38.
5 months (95% CI, 37-39), while the median PFS of patients with TP53 wild type had not been reached (P<0.
0001); similarly, the median OS of patients with TP53 mutation was higher than that of TP53 wild type Patients were significantly shorter (38.
5 months; 95% CI, 37-39 vs not reached, P=0.
0002)
.
5 months (95% CI, 37-39), while the median PFS of patients with TP53 wild type had not been reached (P<0.
0001); similarly, the median OS of patients with TP53 mutation was higher than that of TP53 wild type Patients were significantly shorter (38.
5 months; 95% CI, 37-39 vs not reached, P=0.
0002)
.
The median PFS of patients with TP53 mutation was 38.
The most common treatment-related AEs were diarrhea (38%), neutropenia (36%), fatigue (32%), upper respiratory tract infection (24%), nausea (22%), and arterial hypertension (20%)
AEs
AEsIn conclusion, the study shows that Ibrutinib (ibrutinib) combined with Rituximab (rituximab) is effective in the treatment of indolent mantle cell lymphoma
.
.
Studies have shown that Ibrutinib (ibrutinib) combined with Rituximab (rituximab) is effective in the treatment of indolent mantle cell lymphoma
Original source:
Giné E, de la Cruz F, Jiménez Ubieto A, López Jimenez J, Martín García-Sancho A, Terol MJ, González Barca E, Casanova M, de la Fuente A, Marín-Niebla A, Muntañola A, González-López TJ, Aymerich M, Setoain X, Cortés-Romera M, Rotger A, Rodríguez S, Medina Herrera A, García Sanz R, Nadeu F, Beà S, Campo E, López-Guillermo A.
Giné E, de la Cruz F, Jiménez Ubieto A, López Jimenez J, Martín García-Sancho A, Terol MJ, González Barca E, Casanova M, de la Fuente A, Marín-Niebla A, Muntañola A, González-López TJ, Aymerich M, Setoain X, Cortés-Romera M, Rotger A, Rodríguez S, Medina Herrera A, García Sanz R, Nadeu F, Beà S, Campo E, López-Guillermo A.
Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial.
J Clin Oncol.
2022 Jan 14:JCO2102321.
doi: 10.
1200/JCO.
21.
02321.
Epub ahead of print.
PMID: 35030036.
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