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Brief Title: Brentuximab Vedotin in Refractory/Relapsed Hodgkin Lymphoma Treated by ICE
Official Title: Phase I/II Feasibility Study of Brentuximab Vedotin in Refractory / Relapsed Hodgkin Lymphoma Patients Who Are Treated by Chemotherapy (ICE) in Second Line and Eligible for Autologous Transplantation
Study ID: NCT02686346
Brief Summary: This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen. The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma.
Detailed Description: PHASE I: 3 cycles of Brentuximab Vedotin ICE every 3 weeks and one cycle of Brentuximab Vedotin alone at the doses described below. Cohorts of between three and six evaluable patients will be recruited at each dose level. Dose escalation rules: Treat 3 patients at level K 1. If 0 patients experience dose-limiting toxicity (DLT), escalate to dose K+1 2. If 2 or more patients experience DLT, de-escalate to level K-1 3. If 1 patient experiences DLT, treat 3 more patients at dose level K A. If 1 of 6 experiences DLT, escalate to dose level K+1 B. If 2 or more of 6 experiences DLT, de-escalate to level K-1 Dose escalation will begin at level K. Level K: Brentuximab Vedotin: 1.2 mg/kg (cycle 1-3), 1.8 mg/kg (cycle 4) ICE (cycle 1-3): Etoposide 100 mg/m² (day1 to 3); Carboplatine max 800mg (day 2); Ifosfamide + Mesna 5 g/m² (day 2) Level K -1: Brentuximab Vedotin: 0.8 mg/kg (cycle 1-3), 1.8 mg/kg (cycle 4) ICE (cycle 1-3): Etoposide 100 mg/m² (day1 to 3); Carboplatine max 800mg (day 2); Ifosfamide + Mesna 5 g/m² (day 2) Level K +1: Brentuximab Vedotin: 1.8 mg/kg (cycle 1-3), 1.8 mg/kg (cycle 4) ICE (cycle 1-3): Etoposide 100 mg/m² (day1 to 3); Carboplatine max 800mg (day 2); Ifosfamide + Mesna 5 g/m² (day 2) Dose finding rule: Provisional dose levels are listed in previous tables. Dose-escalation will continue until Maximal Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) is reached or the full doses of BV and ICE are delivered without DLT PHASE II: 3 cycles of Brentuximab Vedotin + ICE every 3 weeks and one cycle Brentuximab Vedotin alone. The recommended dose of BV and ICE will be determined by the phase I Brentuximab Vedotin: MTD mg/kg (cycle 1-3), 1.8 mg/kg (cycle 4) ICE (cycle 1-3): Etoposide 100 mg/m² (day1 to 3); Carboplatine max 800mg (day 2); Ifosfamide + Mesna 5 g/m² (day 2) The recommended dose of BV and ICE will be determined by the phase I.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Clinique Universitaire Saint-Luc, Bruxelles, , Belgium
CHU Dinant Godinne, Yvoir, , Belgium
Institut d'Hématologie de Basse Normandie - CHU Côte de Nacre, Caen, , France
APHP-Hôpital Henri Mondor, Créteil, , France
CHU de Dijon - Hôpital le Bocage, Dijon, , France
CHRU Lille - Hôpital Claude Huriez, Lille, , France
Centre Léon Bérard, Lyon, , France
CHU Saint Eloi, Montpellier, , France
CHU De Nantes, Nantes, , France
APHP - Hôpital Saint Louis, PARIS Cedex 10, , France
Hôpital Necker, Paris, , France
CHU Lyon Sud, Pierre Bénite Cedex, , France
CHU de Poitiers - Hôpital de La Milétrie, Poitiers, , France
CHU De Rennes, Rennes, , France
Centre Henri Becquerel, Rouen, , France
CHU De Strasbourg, Strasbourg, , France
IUCT Toulouse, Toulouse, , France
CHU De Nancy - Hôpital Brabois, Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy, VILLEJUIF Cedex, , France
Name: Pauline Brice, MD
Affiliation: Lymphoma Study Association
Role: PRINCIPAL_INVESTIGATOR
Name: Aspasia Stamatoullas Bastard, MD
Affiliation: Lymphoma Study Association
Role: PRINCIPAL_INVESTIGATOR