Ibrutinib plus Obinutuzumab as Frontline Therapy for Chronic Lymphocytic Leukemia Is Associated with a Lower Rate of Infusion-Related Reactions and with Sustained Remissions after Ibrutinib Discontinuation: A Single-Arm, Open-Label, Phase 1b/2 Clinical Trial NCT0231576.

Q3 Medicine Advances in Hematology Pub Date : 2022-01-22 eCollection Date: 2022-01-01 DOI:10.1155/2022/4450824
Januario E Castro, Paula A Lengerke-Diaz, Juliana Velez Lujan, Michael Y Choi, Eider F Moreno-Cortes, Jose V Forero, Juan Esteban Garcia-Robledo, Chaja Jacobs, Colin McCarthy, Alaina Heinen, Carlos I Amaya-Chanaga, Thomas J Kipps
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引用次数: 2

Abstract

Ibrutinib-based therapies are costly and require continuous administration. We hypothesized combining BTK inhibition with anti-CD20 monoclonal antibodies would yield deep remissions allowing discontinuation. We enrolled 32 therapy-naïve CLL patients to receive ibrutinib plus obinutuzumab, followed by single-agent ibrutinib. Patients could discontinue ibrutinib after 36 months with sustained complete response (CR). We evaluated treatment safety, efficacy, and outcomes after ibrutinib discontinuation. The overall response rate was 100%, 28% achieved a CR, and 12.5% achieved bone marrow undetectable minimal residual disease. At a three-year median follow-up, 91% remain in remission with 100% overall survival. Five patients in sustained CR stopped ibrutinib and have not progressed. Eight non-CR patients discontinued for other reasons, with only two progressing. The treatment was safe, with a lower IRR rate. All patients responded to treatment with longer time-to-progression after discontinuation of ibrutinib. Our data support the evaluation of ibrutinib discontinuation strategies in more extensive clinical trials (https://Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT02315768).

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一项单臂、开放标签、1b/2期临床试验NCT0231576: Ibrutinib + Obinutuzumab作为慢性淋巴细胞白血病的一线治疗与较低的输注相关反应率和Ibrutinib停药后持续缓解相关
以伊鲁替尼为基础的治疗是昂贵的,需要持续给药。我们假设将BTK抑制与抗cd20单克隆抗体结合将产生深度缓解,允许停药。我们招募了32名therapy-naïve CLL患者接受依鲁替尼联合奥比努单抗治疗,随后接受单药依鲁替尼治疗。患者可在持续完全缓解(CR) 36个月后停用依鲁替尼。我们评估了伊鲁替尼停药后的治疗安全性、有效性和结果。总有效率为100%,28%达到CR, 12.5%达到骨髓无法检测到的微小残留疾病。中位随访3年,91%的患者仍处于缓解期,总生存率为100%。5例持续CR患者停止使用依鲁替尼,没有进展。8例非cr患者因其他原因停药,仅有2例进展。治疗是安全的,IRR率较低。所有患者在停用伊鲁替尼后对治疗有反应,但进展时间较长。我们的数据支持在更广泛的临床试验中对伊鲁替尼停药策略的评估(https://Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT02315768)。
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来源期刊
Advances in Hematology
Advances in Hematology Medicine-Hematology
CiteScore
3.30
自引率
0.00%
发文量
10
审稿时长
15 weeks
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