A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin’s Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy

Korábbi kezelés

• Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives (or 28 days if the half-lives are unknown) of last dose of that prior treatment
• Focal radiation therapy within 30 days prior to study recruitment
• Major surgery within 28 days prior to randomization
• Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
• Prior treatment with brentuximab vedotin
• Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose

Más betegség

• Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
• Known human immunodeficiency virus (HIV) positive (in case of Anti-HIV positive result patient cannot be included in the study)
• Known hepatitis B surface or core antigen-positive (HBsAg/ HBcAg). In case of Anti HBc positive result, DNA-HBV must be determined and negative result will allow patient inclusion. Known or suspected active hepatitis C infection. In case of Anti-HCV positive result, RNA-HCV must be determined and negative result will allow patient inclusion.
• Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to the protocol
• Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML
• Symptomatic neurologic disease compromising normal activities of daily living or requiring medic

Laborértékek

• Lymphocyte predominant nodular Hodgkin’s lymphoma
• Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
• Known history of any of the following cardiovascular conditions: Myocardial infarction within 2 years of enrollment; 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%

Egyéb

• Any sensory or motor peripheral neuropathy greater than or equal to Grade 2

• Male or female patients 18 years or older up to 65 years of age
• Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
• Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if 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 agrees to completely abstain from heterosexual intercourse
• Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse
• ECOG performance status 0 to 2
• Measurable disease at time of enrolment (lymphadenopathy/ extranodal mass of at least 1.5 cm)
• No evidence of neuropathy grade ≥2
• Clinical laboratory values as specified below within 7 days before the first dose of study drug: Absolute neutrophil count ≥ 1,500/µL unless there is known hematologic/solid tumor marrow involvement; Platelet count ≥ 75,000/ µL unless there is known marrow involvement of the disease; 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; ALT or AST must be < 3 x the upper limit of the normal range; AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver; Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute; Hemoglobin must be ≥ 8g/dL