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العنوان
PHASE II STUDY COMPARING TREATMENT WITH R-DHAP VERSUS DHAP IN RELAPSED & REFRACTORY AGGRESSIVE DIFFUSE LARGE B-CELL LYMPHOMA/
المؤلف
Rashwan,Ahmad Al-Sayed Onsi
هيئة الاعداد
باحث / احمد السيد أنسي
مشرف / لبني راشد عز العرب
مشرف / عمرو شفيق توفيق
مشرف / دعاء عاطف محمد
تاريخ النشر
2015
عدد الصفحات
146.p:
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
الأشعة والطب النووي والتصوير
تاريخ الإجازة
1/1/2016
مكان الإجازة
جامعة عين شمس - كلية الطب - Clinical Oncology
الفهرس
Only 14 pages are availabe for public view

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from 146

Abstract

This is a randomized phase II prospective clinical trial conducted in Ain-Shams University Hospitals in the period between February 2015 and February 2016. It included forty eligible patients with a histological diagnosis of relapsed or refractory diffuse large B-cell lymphoma. Patients were divided into 2 arms, each arm composed of twenty patients. All patients were received treatment after signed consent was obtained. This study will include 2 arms of randomized patients. Each arm is composed of 20 patients with relapsed or refractory DLBCL. Prospective intervention, using a convenient sample of patient with the inclusion / exclusion criteria to fulfill the calculation sample.Arm I: Patients receive R-DHAP rituximab (375 mg/m2),cisplatin (100 mg/m2) on day 1 via continuous 24-hour infusion, followed on day 2 by cytarabine (2 g/m2) in a 3-hour infusion repeated after 12 hours, and dexamethasone (40 mg/d) for 4 consecutive days. Arm II: Patients receive DHAP cisplatin (100 mg/m2) on day 1 via continuous 24-hour infusion, followed on day 2 by cytarabine (2 g/m2) in a 3-hour infusion repeated after 12 hours, and dexamethasone (40 mg/d) for 4 consecutive days. Patients are reassessed after 3 cycles After completing 3 cycles the response was evaluated according to RECIST criteria 1.1. There were 2 CR (10%) and 4 PR (20%) in DHAP group, while in R-DHAP group there were 8 CR (40%) and 3 PR (15%). But, a 30% response rate (10% CR rate, 20% PR rate) in DHAP group, and 55 % response rate (40% CR rate, 15% PR rate) in R-DHAP group were observed if all patients are considered. The difference was insignificant between the two groups (P-value = 0.089).