BRENTUXIMAB VEDOTIN ASSOCIATED WITH CHEMOTHERAPY IN UNTREATED PATIENTS WITH STAGE I/II UNFAVOURABLE HODGKIN LYMPHOMA - A RANDOMIZED STUDY
- Conditions
- ntreated patients with histologically confirmed CD30+ classical Hodgkin lymphoma (stage I/II), aged > or = 18 and < or = 60 years old, with at least one unfavourable clinical pronostic factorMedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000182-37-DK
- Lead Sponsor
- YSARC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
• Histologically confirmed CD30+ classical Hodgkin lymphoma according to local evaluation
• Supradiaphragmatic Ann Arbor clinical stage I or II
• Previously untreated
• PET scan without IV contrast at diagnosis available for central review with at least one hypermetabolic lesion
• Unfavourable (U) characteristics according to the classic EORTC/LYSA clinical prognostic factors. Unfavourable (U) subset includes patients with at least one of the following factors:
o = 4 nodal areas
o age = 50 yrs
o M/T ratio = 0.35
o ESR = 50 (without B-symptoms) or ESR = 30 with B-symptoms
• ECOG performance status 0-2
• Life expectancy > 6 months
• Age 18 to 60 years (= 18 years to = 60 years)
• Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
• Female patients who:
o Are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile,
OR
o if they are 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 agree to completely abstain from heterosexual intercourse
• Male patients, even if surgically sterilized (ie, status postvasectomy), who:
o 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.
• Patients must give written informed consent. A copy of the informed signed consent form will be retained in the patient’s chart.
• Required baseline laboratory data:
o Absolute neutrophil count = 1,500/µL
o Platelet count = 75,000/ µL
o Hemoglobin = 8g/dL
o Serum total bilirubin = 1.5 X ULN unless the elevation is known to be due to Gilbert syndrome.
o Serum creatinine = 2.0 mg/dL and/or calculated creatinine clearance > 40 mL/minute (Cockcroft-Gault formula or MDRD)
o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 X 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 170
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Histological diagnosis different from classical Hodgkin Lymphoma. Nodular lymphocyte predominant subtypes (nodular paragranuloma or Poppema paragranuloma) are excluded.
• Known cerebral or meningeal disease of any etiology, including signs or symptoms of PML
• Any sensory or motor peripheral neuropathy = Grade 2
• Known history of any of the following cardiovascular conditions
o Myocardial infarction within 2 years of randomization
o New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 14)
o 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
o Recent evidence (within 30 days before first dose of study drug) of a left-ventricular ejection fraction <50%
• Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan).
• Known HIV positive
• HCV positive
• HBV positive. This means:
o HBsAg positive
o HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA
o Note:
Patients who are HBsAg negative and viral DNA negative are eligible
Patients who are seropositive due to a history of hepatitis B vaccine are eligible.
• Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors. Carcinoma in situ of any type are not excluded if they have undergone complete resection.
• Dementia or altered mental status that would preclude compliance with drug delivery
• Pregnancy or breastfeeding. Females of childbearing potential having a positive ß-HCG pregnancy test result during screening or a positive pregnancy test (urinary or blood) within 1 day before start of treatment.
• Previous treatment with any anti-CD30 antibody.
• Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation or known contra-indication to any drug contained in the chemotherapy regimens (for ex.: pulmonary or neurological disease grade = 2)
• Treatment with corticosteroids before baseline PET scan (PET 0)
• Patients with known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy or with untreated known active Grade 3 viral, bacterial, or fungal infection, within 2 weeks prior to the first dose of brentuximab vedotin
• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy or immune-chemotherapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method