Status:
COMPLETED
Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD
Lead Sponsor:
The Lymphoma Academic Research Organisation
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed cluster of differentiation antigen 30+ (CD30+) classical Hodgkin lymphoma
- Patients must have provided voluntary written informed consent
- Supradiaphragmatic Ann Arbor clinical stage I or II
- Mandatory PET scan performed at diagnosis
- Patients treated with first-line ABVD and PET scan positive after 2 cycles (Deauville score 4 \& 5)
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy \> 6 months
- Patients must be 18-65 years of age
- Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution
- 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
- 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
- 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
- Patient affiliated to social security system
Exclusion
- Patients with dementia or altered mental status that would preclude compliance with drug delivery
- Women who are pregnant or breastfeeding
- Patients with symptomatic pulmonary disease
- 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%
- 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
- 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
- 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
- Known Human Immunodeficiency Virus (HIV), known or suspected hepatitis C Virus (HCV) or human T-cell lymphotrophic virus (HTLV) serology positivity
- Patients who have been treated previously with any anti-CD30 antibody
- Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation
- Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy (PML)
- Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02298283
Start Date
April 1 2015
End Date
July 9 2020
Last Update
July 26 2021
Active Locations (30)
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1
CH Victor Dupouy
Argenteuil, France, 95100
2
Polyclinique Bordeaux Nord
Bordeaux, France, 33300
3
Centre François Baclesse
Caen, France, 14076
4
CH de Chambéry
Chambéry, France, 73011