Hodgkin Lymphoma
Conditions
Keywords
Hodgkin lymphoma, HL, brentuximab vedotin
Brief summary
This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).
Detailed description
This study aims to evaluate the progression free survival after treatment for patient with stage I/II supradiaphragmatic HL patient and PET positive after 2 courses of ABVD. The treatment consist of 3 phases : * induction treatment with 2 cycles every 3 weeks of bleomycin, etoposide, Adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone (BEACOPP) escalated * radiotherapy 30 Gy starting 3 to 4 weeks after last day of second course of BEACOPP-escalated * consolidation treatment with 8 cycles every 21 days of brentuximab vedotin
Interventions
DRUGbrentuximab vedotin
is 1.8 mg/kg administrated by IV infusion
DRUGCyclophosphamide
1250 mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
DRUGAdriamycin
35mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
DRUGOncovin
1.4 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
DRUGBleomycin
10 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
DRUGEtoposide
200 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D3 of 2 BEACOPP cycles, every 3 weeks
DRUGProcarbazine
100 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks
DRUGPrednisone
40 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks
DRUGG-CSF
5 µg/kg/j, SC, D9 until GB 1.0x109/L
RADIATION30 Grays
30 Gy radiation of sites initially diagnoses + 6Gy for residual sites, 3 to 4 weeks after D1 of BEACOPP cycle 2.
Sponsors
The Lymphoma Academic Research Organisation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must have histologically confirmed cluster of differentiation antigen 30+ (CD30+) classical Hodgkin lymphoma 2. Patients must have provided voluntary written informed consent 3. Supradiaphragmatic Ann Arbor clinical stage I or II 4. Mandatory PET scan performed at diagnosis 5. Patients treated with first-line ABVD and PET scan positive after 2 cycles (Deauville score 4 & 5) 6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Life expectancy \> 6 months 8. Patients must be 18-65 years of age 9. Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution 10. Female patients who: * Are postmenopausal for at least 1 year before the screening visit OR are surgically sterile OR * If they are of childbearing potential, agree to practice 2 effective methods of contraception at the same time 11. Male patients, even if surgically sterilized, who agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse 12. Clinical laboratory values as specified below before the first dose of study drug: * Absolute neutrophil count ≥ 1,500/µL * Platelet count ≥ 75,000/ µL * Total bilirubin must be \< 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)must be \< 3 x the upper limit of the normal range * Serum creatinine must be \< 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance \> 40 mL/minute * Hemoglobin must be ≥ 8g/dL 13. Patient affiliated to social security system
Exclusion criteria
1. Patients with dementia or altered mental status that would preclude compliance with drug delivery 2. Women who are pregnant or breastfeeding 3. Patients with symptomatic pulmonary disease 4. Patients with known history of any of the following cardiovascular conditions: * Myocardial infarction within 2 years of inclusion * New York Heart Association (NYHA) Class III or IV heart failure * 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% 5. Any history of cancer or cancer treatment during the last 3 years with the exception of non-melanoma skin cancer or stage 0 (in situ) carcinoma of any type if they have undergone complete resection 6. Uncontrolled infectious disease, including active Hepatitis B Virus (HBV) infection defined by either detection of Hepatitis B surface (HBs) Antigen or presence of Hepatitis B core (HBc) antibody without detectable anti HBs antibody 7. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics at the time of inclusion and planned to be still on going within 2 weeks prior to first study drug dose 8. Known Human Immunodeficiency Virus (HIV), known or suspected hepatitis C Virus (HCV) or human T-cell lymphotrophic virus (HTLV) serology positivity 9. Patients who have been treated previously with any anti-CD30 antibody 10. Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation 11. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy (PML) 12. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2 13. 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 | Description |
|---|---|---|
| Progression free survival (PFS) | 2 years | PFS is defined as the time from the date of the first cycle of ABVD to the first observation of documented disease progression or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response rate (CR rate) | 35 weeks | according to Cheson 2007 |
| Overall survival | 4 years | — |
Countries
France
Outcome results
None listed