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

Polish Lymphoma Research Group

Status and phase

Completed

Phase 2

Conditions

Hodgkin's Lymphoma

Treatments

Drug: Dexamethasone

Drug: Bendamustine

Drug: Gemcitabine

Procedure: Autologous Stem Cell Transplant

Diagnostic Test: PET/CT

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT03615664

PLRG-HL1

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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