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

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