Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Test of bendamustine in combination with gemcitabine and vinorelbine could contribute to a higher response rate with the reduction of toxic side effects

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Armando Santoro, MD
• Treatments: Bendamustine Hydrochloride; Gemcitabine; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• relapsed/refractory disease after receiving one line of standard chemotherapy

• history of classical Hodgkin's Lymphoma (HL)

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

• at least one site of measurable nodal disease at baseline ≥ 1.5 cm

• Absolute Neutrophils Count (ANC) ≥ 1.5 x 109/L; Platelets count ≥ 75 x 109/L

Exclusion Criteria:

• Diagnosis of Nodular lymphocyte predominant Hodgkin's lymphoma (NLPHL)

• prior radiation therapy ≤ 3 weeks prior to start of study treatment

• any concurrent anti-cancer therapy

• evidence of another malignancy not in remission or history of such a malignancy within the last 2 years.

• aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x upper limit of normal (ULN) or ≥ 5.0 x ULN if the transaminase elevation is due to disease involvement

• known history of Human immunodeficiency virus (HIV)seropositivity

• hepatitis B virus (HBV) or hepatitis B virus (HCV)active hepatitis