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-NL
- Lead Sponsor
- YSARC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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
oage = 50 yrs
oM/T ratio = 0.35
oESR = 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:
oAre postmenopausal for at least 1 year before the screening visit, OR are surgically sterile,
OR
oIf 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:
oAgree 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:
oAbsolute neutrophil count = 1,500/µL
oPlatelet count = 75,000/ µL
oHemoglobin = 8g/dL
oSerum total bilirubin = 1.5 X ULN unless the elevation is known to be due to Gilbert syndrome.
oSerum creatinine = 2.0 mg/dL and/or calculated creatinine clearance > 40 mL/minute (Cockcroft-Gault formula or MDRD)
oAlanine 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
oMyocardial infarction within 2 years of randomization
oNew York Heart Association (NYHA) Class III or IV heart failure (see Appendix 14)
oEvidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
oRecent 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:
oHBsAg positive
oHBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA
oNote:
?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