Spots Global Cancer Trial Database for BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant
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Trial Identification
Brief Title: BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant
Official Title: A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy With Brentuximab Vedotin-ESHAP vs ESHAP in Patients With Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (Instead of Autologous Hematopoietic Stem Cell Transplantation) in Those Who Attained a Metabolic Complete Remission After Salvage Therapy
Study ID: NCT04378647
Conditions
Study Description
Brief Summary: A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy
Detailed Description: A phase IIb open label multi-center trial in patients with refractory / relapsed cHL. Patients are randomized (1:1) to receive: • ESHAP- BV (Etoposide \[40 mg/m2/ day IV, D1-4\], Solumedrol \[250 mg/day IV, D1-4\], high dose Ara-C \[2 g/m2 IV, D5\] and cisplatinum \[25 mg/m2/day IV, D1-4\] + BV \[1.8 mg/kg IV, D1\], every 21 days (3 cycles, q21 days). Or • ESHAP (Etoposide \[40 mg/m2/ day IV, D1-4\], Solumedrol \[250 mg/day IV, D1-4\], high dose Ara-C \[2 g/m2 IV, D5\] and cisplatinum \[25 mg/m2/day IV, D1-4\] (3 cycles, q21 days) Stem cell collection will be performed in all patients according to institutional guidelines, but preferably after the first / second cycle of ESHAP-BV or ESHAP. Patients attaining a mCR (Deauville 1, 2) after receiving 3 cycles of ESHAP-BV, will receive up to 13 cycles of BV consolidation (administered every 3 weeks, over 39 weeks). Patients who were randomized to ESHAP and attained a mCR after receiving 3 cycles will receive up to 16 cycles of BV (same dosage and time intervals). Patients who attained less than mCR following ESHAP-BV/ESHAP they will be taken out of the trial and will be treated according to their physician's clinical decision. However, they will be followed in order to evaluate their clinical outcome in terms of ORR, CR rate, TTNT2 and OS, that will be analyzed the study separately.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Institut Català D'Oncologia - Hospital Germans Trias I Pujol, Barcelona, Barceolna, Spain
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Complexo Hospitalario Universitario A Coruña, A Coruña, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau, BArcelona, , Spain
Institut Català D'Oncologia - Hospital Duran I Reynals, Barcelona, , Spain
Institut Català D'Oncologia, Barcelona, , Spain
Hospital Universitario de Cruces, Bilbao, , Spain
Hospital Universitario Virgen de Las Nieves, Granada, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Ramón Y Cajal, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, MAdrid, , Spain
Hospital General Universitario J.M. Morales Meseguer, Murcia, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen Del Rocío, Sevilla, , Spain
Hospital Universitario Y Politécnico La Fe, Valencia, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Contact Details
Name: Anna Sureda, PhD
Affiliation: Institut Català d'Oncologia, Hospital Duran i Reynals
Role: PRINCIPAL_INVESTIGATOR
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