Hodgkin’s Lymphoma MedDRA version: 17.0 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Sponsors
Fondazione Italiana Linfomi Onlus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Classical Hodgkin Lymphoma according to the World Health Organisation (WHO) classification 2. Histologically confirmed CD30+ HL at diagnosis 3. Patients at the first line salvage therapy 4. FDG-PET positivity after two cycles of IGEV treatment 5. PBPCs should have been collected after the first or the second IGEV cycle 6. Age= 18 years 7. ECOG performance status of 0-2 8. Life expectancy > 6 months. 9. Written informed consent was obtained from the patient prior to any study-specific screening procedures 10. Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution 11. Females of childbearing potential must have a negative ß-HCG pregnancy test result (pregnancy test should be performed at screening an on day 1 of cycle 1 prior to brentuximab vedotin treatment). 12. Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse. 13. Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse. 14. Required baseline laboratory data: - Absolute neutrophil count = 1500/µl - Platelet count = 75.000/ µl - Haemoglobin must be = 8 g/dL - Serum bilirubin = 1.5 times ULN - Serum creatinine 40 mL/minute. - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times ULN Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Peripheral neuropathy > Grade 1 2. Histologic diagnosis different from Hodgkin Lymphoma 3. First line treatment with BEACOPP 4. Compressive symptoms caused by the presence of Lymphoma 5. Patients who have been treated previously with any anti-CD30 antibody. 6. Known hypersensitivity to any recombinant proteins, murine proteins, or excipients contained in the brentuximab vedotin formulation. 7. Known human immunodeficiency virus (HIV) positive 8. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection 9. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 10. Patients with known history of any of the following cardiovascular conditions : • Myocardial infarction within 2 years of randomization • New York Heart Association (NYHA) Class III or IV heart failure (see Appendix E) • Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities • Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50% 11. Patients with known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of brentuximab vedotin. 12. Patients with known active Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin. 13. Patients with known cerebral/meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy (PML). 14. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to protocol. 15. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications. 16. Patients who are pregnant, or lactating and breastfeeding. 17. Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity of brentuximab vedotin in terms of complete remission (CT scan and FDG-PET negative) in patients with relapsed/refractory Hodgkin’s Lymphoma not responding (FDG-PET positive) to salvage treatment with IGEV. ;Secondary Objective: To evaluate if brentuximab vedotin administration after unsatisfactory response to IGEV is able to achieve CR, thus improving progression free survival (PFS) and duration of remission. To evaluate the toxicity of brentuximab vedotin in terms of haematological and extra-haematological side effects according to the NCI CTCAE (Version 4.03). ;Primary end point(s): CR rate;Timepoint(s) of evaluation of this end point: 1 year and half from the beginning of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity and PFS;Timepoint(s) of evaluation of this end point: Toxicity: 1 year and half from the beginning of the study PFS: 2 years and half from the beginning of the study | — |
Countries
Italy
Contacts
Public ContactSecretariat
Fondazione Italiana Linfomi Onlus
Outcome results
None listed