NCT03615664

The Efficacy of Salvage BGD With autoSCT Consolidation in Advanced Classical HL Patients Not Responding to ABVD

The Efficacy of Bendamustine, Gemcytabine, Dexamethasone (BGD) Salvage Chemotherapy With autoSCT Consolidation in Advanced Classical HL Patients Not Responding to ABVD - Multicentre Phase II Clinical Study - PLRG-HL1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Polish Lymphoma Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is evaluation of efficacy of Bendamustine, Gemcytabine, Dexamethasone (BGD) salvage therapy with autologus stem cell transplantation (ASCT) consolidation in advanced classical Hodgkin lymphoma patients not responding to ABVD therapy.

Detailed description

Treatment regimen: Bendamustine (B) 90 mg/m2 iv day 1, 2 Gemcytabine (G) 800 mg/m2 iv day 1, 4 Dexamethasone (D) 40 mg iv/po day 1,2,3,4 Course of treatment every 21-28 days, 4 courses of treatment max; next round of treatment may be given if ANC\>1000/μl and PLT\>75000/μl. Up to 7-day delay is permitted.

Conditions

• Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine	Bendamustine (B) 90 mg/m2 i.v. day 1, 2
DRUG	Gemcitabine	Gemcitabine (G) 800 mg/m2 i.v. day 1, 4
DRUG	Dexamethasone	Dexamethasone (D) 40 mg i.v./p.o. day 1,2,3,4
DIAGNOSTIC_TEST	PET/CT	PET scan/CT must be performed after first 2 courses of BGD treatment. Results evaluation: * in case of a CMR/CR or PMR/PR, ASCT must be performed within 3 months after the end of BGD treatment * in case of SMD - exclusion from the trial * in case of PMD - exclusion from the trial
PROCEDURE	Autologous Stem Cell Transplant	Must be performed within 3 months after the end of BGD treatment. When it is not possible to perform ASCT, despite CMR or PMR response, within 3 months after second course of BGD treatment, it is permissible to extend the therapy up to 4 cycles. PET scan/CT must be repeated before performing ASCT.

Timeline

• Start date: 2017-11-06
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2018-08-06
• Last updated: 2025-01-16

Locations

13 sites across 1 country: Poland