NCT04378647

BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin Lymphoma, Adult

Interventions

Type	Name	Description
DRUG	Induction with Brentuximab vedotin (BV)	3 cycles ESHAP plus antibody-drug conjugate brentuximab vedotin (BV) at a dose of 1.8 mg/kg IV
DRUG	Induction without Brentuximab Vedotin	3 cycles of ESHAP as a standard of care therapy for those patients with primary refractory cHL and those patients relapsing after first-line therapy
DRUG	Consolidation with Brentuximab Vedotin	Up to 13 or 16 cycles of antibody-drug conjugate brentuximab vedotin (BV) at doses of 1.8 mg/kg iv every 21 days)

Timeline

• Start date: 2020-06-01
• Primary completion: 2026-08-30
• Completion: 2026-08-30
• First posted: 2020-05-07
• Last updated: 2024-02-26

Locations

19 sites across 1 country: Spain