Clinical trial · Interventional
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
NCT03615664CI-TRIAL-00084803BURGUNDcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Stem Cell Transplant | Procedure | — | UNRESOLVED |
| Bendamustine | Drug | Bendamustine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BGD therapy
- description
- Bendamustine, Gemcitabine, Dexamethasone
- interventionNames
- Drug: Bendamustine
- Drug: Gemcitabine
- Drug: Dexamethasone
- Diagnostic Test: PET/CT
- Procedure: Autologous Stem Cell Transplant
Primary outcomes (2)
- measure
- ORR (overall response rate)
- timeFrame
- Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)
- description
- CR (complete response) + PR (partial response)
- measure
- PFS (progression-free survival)
- timeFrame
- Time measured from date of of Cycle 2 of BGD treatment (every cycle is 21-28 days) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed Classical Hodgkin's Lymphoma treated with ABVD regimen with PET scan/CT performed before, during and after treatment, and also one of the following: * positive result (Deauville 4 and 5) of early PET scan after 2 ABVD courses * disease progression or relapse after first-line ABVD treatment or ABVD and radiotherapy combination treatment * No contraindications for salvage chemotherapy and ASCT * At least one measurable malignancy * ECOG performance status ≤ 3 * Written signed and dated informed consent prior to any study procedures being performed Exclusion Criteria: * Non-Classical Hodgkin's Lymphoma * Other than ABVD first-line treatment, preceding patient's inclusion * Lack of PET scans performed in accordance with inclusin criteria during ABVD treatment * Transformation of Hodgkin's Lymphoma * Central Nervous System (CNS) Metastases * Contraindications for ASCT or lack of patient's consens for the procedure * Second malignancy - active or cured less than 5 years prior * Uncontrolled diabetes * Hepatic impairment (bilirubin concentration ≥ 1.5 x ULN, SGOT \> 5 x ULN), if non-realted to the lymphoma or Gilbert's syndrome * HIV infection * Active HBV or HCV infection. Subjects who have had Hepatitis B and are abHBC positive, need to undergo HBV DNA test using a Polymerase Chain Reaction (PCR) technique and be applied appropriate preventive treatment. * Pregnancy or lactation * Hypersensitivity to any of the drugs * Lack of written informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.