Hodgkin Lymphoma MedDRA version: 18.1 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 100000004864
Conditions
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed CD30+ HL, primarily refractory to first line chemotherapy or in first relapse after any polychemotherapy regimen 2. Measurable disease defined as at least one single node or tumor lesion on CT scan > 1.5 cm 3. FDG-PET/ CT realized at relapse and positive. 4. Age = 18 years and up to 65 years 5. ECOG Performance Status = 2 6. Life expectancy of > 3 months with treatment 7. No major organ dysfunction, unless HL-related 8. Normal cardiac and pulmonary function for auto transplantation 9. Eligible for high dose chemotherapy and autologous peripheral blood stem cell transplantation 10. Resolution of toxicities from first-line therapy 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 55 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Peripheral sensory or motor neuropathy grade = 2 2. Any chemotherapy, radiotherapy, immunotherapy or investigational, therapy for treatment of lymphoma within 28 days prior C1D1 3. Patient who have been treated by first line of treatment with brentuximab vedotin alone or in combination 4. Female patients who are both lactating and breast feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test prior C1D1 5. Patients with active, uncontrolled infections (requiring systemic antibiotics within two weeks prior to treatment 6. Prior history of another cancer unless the subject has been free of the disease for = 3 years (with the exception of non-melanoma skin cancer, completely resected melanoma TNMpT1 or carcinoma in situ of the uterine cervix) 7. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML 8. Patients with known HIV seropositivity, hepatitis B, hepatitis C (Ag detection of HBs Antigen or presence of anti HBc antibody without detectable anti HBs antibody) 9. Patients having received radiation therapy within 8 weeks prior C1D1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I To determine the MTD and/or RP2D (Recommended Phase II dose) of BV when administered to adult Hodgkin’s lymphoma patients treated with ICE. Phase II To evaluate the efficacy of BV in patient treated with ICE as first salvage treatment (establish the fraction of responding patients – metabolic CR) acccording to Lugano classification after the second cycle.;Secondary Objective: Phase I - To characterize the safety and tolerability of BV in patient treated with ICE. - To assess preliminary anti-tumor activity of BV in patient treated with ICE. Phase II - To assess the ORR (CR and PR) after 3 cycles of BV and ICE and one cycle of BV - To assess the toxicity profile of BV in patient treated with ICE - To assess hematological recovery after each cycle of BV and ICE - To assess the feasibility of harvesting an autologous peripheral blood stem cell graft after BV in patient treated with ICE - To assess the fraction of patients (CR/PR) eligible for auto- PBSCT who actually undergo one or two auto-PBSCT - To assess the number of patients with PET 4 negative if the PET 2 is positive - To evaluate PFS and OS with this treatment regimen Exploratory objectives : - To identify predictive factors for response, PFS and OS (for phase II only);Primary end point(s): Phase I : MTD Phase II : metabolic CR;Timepoint(s) of evaluation of this end point: Phase I : end of treatment Phase II : end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I - Efficacy, Safety - Anti-tumor activity Phase II - ORR (CR and PR) after 3 cycles of BV and ICE and one cycle of BV - toxicity profile of BV - hematological recovery after each cycle of BV and ICE - feasibility of harvesting an autologous peripheral blood stem cell graft after BV in patient treated with ICE - fraction of patients (CR/PR) eligible for auto- PBSCT who actually undergo one or two auto-PBSCT - number of patients with PET 4 negative if the PET 2 is positive - PFS - OS ;Timepoint(s) of evaluation of this end point: Phase I : end of treatment Phase II - ORR : after 3 cycles of BV and ICE and one cycle of BV - toxicity profile of BV : end of treatment - hematological recovery : after each cycle of BV and ICE - feasibility of auto-PBSCT : end of treatment - fraction of patients (CR/PR) eligible for auto- PBSCT who actually undergo one or two auto-PBSCT : end of treatment - number of patients with PET 4 negative if the PET 2 is positive : PET 4 - PFS : end of study - OS : end of study | — |
Countries
Belgium, France
Contacts
Public ContactSabine BALOUET
LYSARC
Outcome results
None listed