PHASE II STUDY OF BENDAMUSTINE, GEMCITABINE AND VINORELBINE AS INDUCTION THERAPY IN HODGKIN’S LYMPHOMA FAILING PRIOR ANTITUMOR TREATMENT, BEFORE HIGH DOSE CHEMOTHERAPY WITH AUTOLOGOUS HEMATOPOIETIC STEM CELLS TRANSPLANT

Phase 1

Conditions: patients with relapsed-refractory Hodgkin's Lymphoma
MedDRA version: 14.1Level: PTClassification code 10020266Term: Hodgkin's disease recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10020267Term: Hodgkin's disease refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2010-022169-91-IT

Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 59

Inclusion Criteria

Patient’s age is = 18 years Patient has relapsed/refractory disease after receiving one line of standard chemotherapy Patient has a history of classical HL Patient has an ECOG performance status of = 2 Patient has at least one site of measurable nodal disease at baseline =1.5 cm Patient has the following laboratory values: ANC = 1.5 x 109/L; Platelets count = 75 x 109/L Written informed consent was obtained from the patient prior to any study-specific screening procedures Sexually mature women must have a negative serum pregnancy test at baseline. Both male and female patients must use a method of contraception
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

History of PDLHL Patient has received prior radiation therapy = 3 weeks prior to start of study treatment Patient is using any anti-cancer therapy concomitantly Patient has evidence of another malignancy not in remission or history of such a malignancy within the last 3 years (except for treated basal or squamous cell carcinoma, or in situ cancer of the cervix). Patient has the following laboratory values: • Serum creatinine = 1.5 x ULN • Serum bilirubin = 1.5 x ULN (or = 3.0 x ULN, if patient has Gilbert syndrome) • AST/SGOT and/or ALT/SGPT = 2.5 x upper limit of normal (ULN) or = 5.0 x ULN if the transaminase elevation is due to disease involvement Patient has a known history of HIV seropositivity Patient has a known history of HBV/HCV active hepatitis Patient enrolled in protocol HD0801, PET2 positive.