Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503276
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
The Treatment of Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma by Orelabrutinib and Radiotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Combination of Orelabrutinib and Ultra-low Dose Radiotherapy in the First-line Treatment of Early Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Extranodal marginal zone B-cell lymphoma EMZL is the most common lymphoma of the ocular adnexa OA accounting for approximately 60 As a special part of the body there is no consensus on the optimal treatment strategy for OA-EMZL Studies have shown that patients who wait for postoperative observation have a 5-year PFS of approximately 80 and a 10-year PFS of 63 Therefore radiotherapy remains an important treatment for stage III OA-EMZL patients but the dosage of radiotherapy remains controversial In 2014 Hoskin PJ et al found that the complete response rate and effective rate of patients in the standard 24Gy radiation dose group were 71 and 91 while those in the 4Gy radiation dose group were 55 and 87 respectively Meanwhile the PFS of patients with 4Gy radiation dose was lower than that of the group with 24Gy radiation dose but there was no significant difference in OS between the two groups However in a study conducted by Chelius M et al in 2021 they found that the incidence of both early and late toxic effects was significantly higher in the4Gy radiation dose group than in the4Gy radiation dose group These toxic effects inevitably affect the quality of life of patients Therefore investigators plan to adopt a combination of ultra-low dose radiotherapy and drug therapy which not only reduces the side effects of radiotherapy but also improves the complete response rate of treatment and reduces disease progression or recurrence However studies have shown that radiotherapy combined with rituximab cannot improve the disease-specific survival rate of OA-EMZL Therefore BTK inhibitors BTKi as a novel targeted drug for the treatment of EMZL have been used to treat relapsed and refractory EZML by interfering with BCR signals Based on the above research investigators plan to explore the efficacy of combination therapy with Orelabrutinib and ultra-low dose radiotherapy 4Gy in the treatment of stage III OA-EMZL
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None