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

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.

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.

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