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

NCT03615664 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-01-16

No results posted yet for this study

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.

Conditions

  • Hodgkin's Lymphoma

Interventions

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.

Sponsors & Collaborators

  • Polish Lymphoma Research Group

    lead NETWORK

Principal Investigators

  • Sebastian Giebel, Prof. · PLRG's Chairman

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03615664 on ClinicalTrials.gov