Dataset Information

Safety of chidamide plus rituximab in elderly patients with relapsed or refractory B-cell lymphoma in China: a multicenter, single-arm, phase II study.

ABSTRACT:

Background

Patients over 65 years old with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) relapse or being refractory to rituximab-associated chemotherapy have limited treatment options. Chidamide has the ability to enhance the sensitivity of rituximab-resistant tumors in vivo has been confirmed. We aimed to assess the activity and safety profile of chidamide plus rituximab in elderly Chinese patients with recurrent or refractory B-cell lymphoma.

Methods

In this prospective, single-arm phase II trial, we enrolled patients from three hospitals in China with histopathological diagnoses of DLBCL and FL who had relapsed or were refractory to previous lines of rituximab-associated chemotherapy. Patients were given chidamide (10 mg on days 1-6 and 8-14) and rituximab (375 mg/m² on day 7). The treatments were repeated every 21 days. The primary endpoint was the objective response rate (ORR). The secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Results

Thirteen patients were enrolled and commenced treatment between November 12, 2018, and December 24, 2020. As of March 20, 2021, two patients (15.4%) were still receiving treatment. The median follow-up was 13.4 months. The ORR was 40% for the DLBCL cohort (n=10), and 100% for the FL cohort (n=3). DLBCL patients had a median PFS (mPFS) of 2.6 months (0.9-31.2 months) and a median OS (mOS) of 16.7 months (2.3-13.6 months). Neither mPFS nor mOS was reached in the FL cohort. The most frequent treatment-related adverse events (TRAEs) were leukopenia (38.5%), neutropenia (30.8%), lymphopenia (30.8%), thrombocytopenia (30.8%), fatigue (38.5%), and hyperuricemia (30.8%).

Conclusions

Chidamide plus rituximab is clinically effective with an acceptable toxicity profile in elderly patients over 65 years old with relapsed or refractory DLBCL and FL. Further investigation is ongoing.

SUBMITTER: Chen X

PROVIDER: S-EPMC8756245 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Publications

Safety of chidamide plus rituximab in elderly patients with relapsed or refractory B-cell lymphoma in China: a multicenter, single-arm, phase II study.

Chen Xinrui X Wang Huaqing H Sun Xiuhua X Su Liping L Liu Fengting F Zhao Ke K Xu Liye L Wu Shaohua S Song Teng T

Annals of translational medicine 20211201 24

<h4>Background</h4>Patients over 65 years old with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) relapse or being refractory to rituximab-associated chemotherapy have limited treatment options. Chidamide has the ability to enhance the sensitivity of rituximab-resistant tumors <i>in vivo</i> has been confirmed. We aimed to assess the activity and safety profile of chidamide plus rituximab in elderly Chinese patients with recurrent or refractory B-cell lymphoma.<h4>Methods</h4> ...[more]

PMID: 35071463

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Project description:BackgroundIn relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), a negative prognosis is frequently linked to heightened epigenetic heterogeneity. Chidamide, a selective histone deacetylase inhibitor, shows promise as a targeted therapy for R/R DLBCL by targeting abnormal epigenetic changes associated with poor prognosis.MethodsA cohort of 27 ineligible patients with R/R DLBCL participated in an open - label, single - arm study. Chidamide was administered orally at a dose of 30 mg twice weekly for one week during the induction monotherapy phase. The subsequent combination therapy phase involved oral chidamide at a dose of 20 mg twice weekly for two weeks, followed by a one-week discontinuation period, in conjunction with intravenous R-GDP every 21 days.ResultsAmong the cohort of 31 patients who underwent screening (median age: 67 years), 27 were ultimately included in the study, with 14 individuals successfully completing six cycles of C-R-GDP treatment. The overall best objective response rate was determined to be 79.1% (95% CI: 75.1%-83.3%), comprising a complete response rate of 45.8% (95% CI: 41.6%-49.9%) and a partial response rate of 33.3% (95% CI: 29.3%-37.4%). Within the subgroup of 14 patients who completed the full treatment regimen, the best objective response rate reached 100%, with 71.4% achieving complete response (n = 10) and 28.6% achieving partial response (n = 4). The median follow-up period for these patients was 17.0 months, ranging from 3.5 to 55 months. Progression-free survival was 5.9 months and overall survival was 48.3 months. Anemia was the most common adverse event, affecting all patients. Thrombocytopenia led to treatment interruption or dose reduction in 13 patients. Other common adverse events included hypocalcemia, hyponatremia, and hypokalemia. Three patients experienced grade 3 pneumonitis and one had grade 3 skin rash.ConclusionsChidamide combined with R-GDP is a safe and effective treatment option for patients with R/R DLBCL who are not eligible for autologous stem cell transplantation.

Dataset Information

Safety of chidamide plus rituximab in elderly patients with relapsed or refractory B-cell lymphoma in China: a multicenter, single-arm, phase II study.

Background

Methods

Results

Conclusions

Publications

Safety of chidamide plus rituximab in elderly patients with relapsed or refractory B-cell lymphoma in China: a multicenter, single-arm, phase II study.

Similar Datasets

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