Spots Global Cancer Trial Database for CHP-BV Followed by Consolidation With High-dose Therapy / ASCT as Frontline Treatment of Patients With EATL Type 1.

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Trial Identification

Brief Title: CHP-BV Followed by Consolidation With High-dose Therapy / ASCT as Frontline Treatment of Patients With EATL Type 1.

Official Title: Phase 2 Study of Brentuximab Vedotin Associated With CHP Followed by Consolidation With High-dose Therapy / Autologous Stem-cell Transplantation as Frontline Treatment of Patients With Enteropathy-associated T-cell Lymphoma Type 1.

Study ID: NCT03217643

Conditions

Enteropathy Associated T-cell Lymphoma

Interventions

Brentuximab Vedotin

Study Description

Brief Summary: It has been recently reported that EATL type 1, but not refractory coeliac disease, strongly expressed CD30 and might benefit from brentuximab vedotin. Since the safety profile of the combination brentuximab vedotin and CHP is known and since the role of etoposide as part of induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity of the combination brentuximab vedotin and CHP followed by HDT/ASCT, as frontline treatment of EATL.

Detailed Description: Brentuximab vedotin is an anti-CD30 monoclonal antibody conjugated to the cytotoxic drug monomethyl auristatin E. It is currently evaluated in combination with multi-agent chemotherapy as frontline treatment of systemic ALCL (sALCL) and other CD30-positive mature T cell and NK cell lymphomas. Preliminary results of this phase 1 study have been presented at the 2012 ASH Annual Meeting: 26 patients have been treated with combination brentuximab vedotin and CHP. Nineteen of 26 patients had a diagnosis of sALCL and 7 patients had a diagnosis of another mature Tor NK-cell lymphoma (EATL, n=1). The maximum tolerated dose of brentuximab vedotin in combination with CHP was not exceeded at 1.8 mg/kg IV. Adverse events were manageable. All patients achieved an objective response, with 23 patients (88%) achieving a complete response (CR). All 7 non-sALCL patients achieved a CR. Finally, it has been recently reported that EATL type 1, but not refractory coeliac disease, strongly expressed CD30 and might benefit from brentuximab vedotin. Since the safety profile of the combination brentuximab vedotin and CHP is known and since the role of etoposide as part of induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity of the combination brentuximab vedotin and CHP followed by HDT/ASCT, as frontline treatment of EATL.