patients with relapsed-refractory Hodgkin's Lymphoma MedDRA version: 14.1 Level: PT Classification code 10020266 Term: Hodgkin's disease recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10020267 Term: Hodgkin's disease refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: RIBOMUSTIN
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: BENDAMUSTINE
CAS Number: 16506277
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the BeGEV scheme efficacy as induction therapy before high dose chemotherapy with AHSCT in patients with relapsed/refractory Hodgkin’s Lymphoma.;Secondary Objective: To evaluate overall response rate (complete and partial remissions), evaluated by CT-scan and FDG- PET after four cycles. To evaluate the mobilization potentially of BeGEV. To evaluate the toxicity of BeGEV in terms of haematological and extra-haematological side effects according to the NCI CTCAE (Version 3.0). Progression free survival and overall survival. (step II);Primary end point(s): To assess the response rate after BeGEV in terms of complete remission (CR) evaluated by CT-scan and FDG- PET after four cycles;Timepoint(s) of evaluation of this end point: after four cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival and overall survival.;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactDIREZIONE SCIENTIFICA
SENDO TECH
Outcome results
None listed