Study of Bendamustine, Gemcitabine and Vinorelbine Regimen in Relapsed/Refractory Classical Hodgkin Lymphoma

Summary

The goal of this phase III clinical trial was to make a direct head to head comparison between the chemotherapeutics; Bendamustine, Gemcitabine and Vinorelbine (BEGEV) and the the Gemcitabine, Dexamethasone and Cisplatin (GDP) regimens in the settings of relapsed and refractory classical Hodgkin lymphoma. Patients were allocated and randomly assigned to either arm. Cycles were received as out-patient setting, every 21 days. Patients were assessed by clinical and routine labs, before receiving the cycle. Efficacy was assessed by performing Positron Emission Tomography (PET-CT) after three cycles. Toxicity was reported according to the National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly. Patients attained at least partial response (PR) was sent for high dose chemotherapy followed by autologous stem cell rescue(HDC/ASCR). Patients were followed up for a total of 1 year

Timeline

Start

2024-04-30

Primary completion

2024-10-30

Completion

2026-02-01

Publications

• Background 1-Ansell SM. Hodgkin lymphoma: 2023 update on diagnosis, risk-stratification, and management. Am J Hematol. 2022; 97(11): 1478-1488. doi:10.1002/ajh.26717 https://onlinelibrary.wiley.com/doi/10.1002/ajh.26717 2-Ansell S.M., Radford J., Connors J.M., Długosz-Danecka M., Kim W.-S., Gallamini A., Ramchandren R., Friedberg J.W., Advani R., Hutchings M., et al. Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma. N. Engl. J. Med. 2022; 387:310-320. doi:10.1056/NEJMoa2206125.https://pubmed.ncbi.nlm.nih.gov/35830649/ 3-Arai S, Fanale M, DeVos S, Engert A et al. Defining a Hodgkin lymphoma population for novel therapeutics after relapse from autologous hematopoietic cell transplant. Leuk Lymphoma.2013; 54:2531-2533. https://doi.org/10.3109/10428194.2013.798868 4-Santoro A, Magagnoli M, Spina M et al. Ifosfamide, gemcitabine, and vinorelbine: a new induction regimen for refractory and relapsed Hodgkin's lymphoma. Haematologica.2007; 92:35-41. https:// doi.org/10.3324/haematol.10661 https://pubmed.ncbi.nlm.nih.gov/17229633/ 5- Santoro A, Mazza R, Pulsoni A et al. Bendamustine in combination with gemcitabine and vinorelbine is an efective regimen as induction chemotherapy before autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma: fnal results of a multicenter phase II study. J Clin Oncol.2016; 34:3293-3299. https://pubmed.ncbi.nlm.nih.gov/27382096/ 6- Stefoni V, Argnani L, Carella M, Casadei B, Morigi A, Lolli G, Broccoli A, Pellegrini C, Nanni L, Coppola PE, Zinzani PL. BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma: a real-life experience. J Cancer Res Clin Oncol. 2023 Mar;149(3):1043-1047. doi: 10.1007/s00432-022-03955-w. Epub 2022 Mar 3. PMID: 35239000; PMCID: PMC9984336. https://pubmed.ncbi.nlm.nih.gov/35239000/ 7- Rybka J, Jurczak W, Giza A, Paszkiewicz-Kozik E, Kumiega B, Drozd-Sokołowska J, Butrym A, Kuliczkowski K, Wróbel T. Gemcitabine-Based Treatment in Poor-Prognosis Patient

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Indications