Hodgkin Lymphoma Patients MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: ADCETRIS
Product Name: Brentuximab Vedotin
Pharmaceutical Form: Powder and solution for solution for injection
Sponsors
CHU CAEN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged =18 or = 65 years 2. Patients who received allo-SCT for relapse after autologous transplantation for Hodgkin’s lymphoma 3. Patients who received tandem autologous and allogeneic stem cell transplantation for HL are eligible 4. Histologically confirmed CD30+ classical Hodgkin lymphoma according to local pathologist (excluding nodular lymphocyte predominant subtype) 5. Patients with Ann Arbor stage II-III or IV or extranodal localization at relapse post ASCT 6. Patients who previously received Bv may be included if the duration of response to initial Bv treatment is more than 3 months 7. Patients who previously received anti-PD1 drugs can be included 8. Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 9. Patients must be covered by a social security system 10. Female patients 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 11. 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. 12. Performance status = 2 13. Clinical laboratory values as specified below within 7 days before the first dose of study drug: -Absolute neutrophil count = 1,000/µL unless there is known hematologic/solid tumor marrow involvement -Platelet count = 75,000/ µL unless there is known marrow involvement of the disease -Total bilirubin must be 40 mL/minute. -Hemoglobin must be = 8g/dL. 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 58 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: 1. Patients with histologically confirmed nodular lymphocyte predominant subtype 2. Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug 3. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to the protocol. 4. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML 5. Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan). 6. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications 7. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2 8. Known history of any of the following cardiovascular conditions ? Myocardial infarction within 2 years of enrollment ? New York Heart Association (NYHA) Class III or IV heart failure(10) (see Appendix 12.2) ? 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% 9. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose 10. 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 11. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of Bv. 12. Known human immunodeficiency virus (HIV) positive 13. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection 14. 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 non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival at 12 months after SCT • Progression free survival at 12 months after allo-SCT • Relapse GVH free survival at 12 months after allo-SCT • Treatment related mortality at 12 months after allo-SCT ;Timepoint(s) of evaluation of this end point: 12 months | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To decrease the cumulative incidence of relapse (CIR) rate by15% at 12 months after allogeneic stem cell transplantation (allo-SCT);Secondary Objective: • To evaluate the Progression free survival (PFS) at 12 months after allo-SCT • To evaluate Non-relapse mortality (NRM) at 12 months after allo-SCT To evaluate Relapse Graft versus host disease free survival (RGFS) at 12 months after SCT ;Primary end point(s): Cumulative incidence of relapse (CIR) or progression at 12 months after allo-SCT;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
France
Contacts
Public ContactInvestigateur coordinateur
CHU CAEN
Outcome results
None listed