Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

Launched by UNIVERSITY COLLEGE, LONDON · Dec 21, 2020

Keywords

ClinConnect Summary

This clinical trial, called RADAR, is studying the effectiveness of two different chemotherapy treatments for patients with early-stage Hodgkin lymphoma. The treatments being compared are ABVD (a standard regimen) and A2VD (which includes the drug brentuximab vedotin). The trial is taking place in various countries, including Europe, Australia, and North America, and aims to determine which treatment works better.

To participate in this trial, candidates must be between 16 and 69 years old and have a confirmed diagnosis of classical Hodgkin lymphoma at an early stage (stage I or II). They should not have received any previous treatment for this type of cancer. Participants can expect to receive 3-4 cycles of chemotherapy, along with possible radiation therapy afterwards, and will have regular follow-ups for at least five years to monitor their health. It's important for potential participants to discuss their medical history with their doctors to see if they meet the criteria for joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males and females aged 16-69 years (inclusive) (age range is 18-69 in US and EU)
• • Histologically confirmed classical Hodgkin lymphoma
• • Stage I or II supradiaphragmatic disease with no mediastinal bulk disease (defined as greater than a third of the transthoracic diameter at any level of thoracic vertebra as determined by CT) or B symptoms. Bulky disease at other sites is acceptable. Extranodal disease (single extranodal site (stage I) or contiguous nodal extension (stage II)) is acceptable.
• • ECOG performance status 0-2.
• • No previous treatment for Hodgkin lymphoma
• • Fit to receive anthracycline-based chemotherapy (patients with a history of ischaemic heart disease or hypertension should have a left ventricular ejection fraction of ≥50%)
• • Creatinine clearance (measured or calculated \>40ml/min
• • Total bilirubin \<1.5 x upper limit of normal, unless attributable to disease or known Gilbert's syndrome
• • ALT or AST \< 2 x upper limit of normal
• • Adequate bone marrow function with neutrophils ≥1.0x10\^9/l and platelets ≥100x10\^9/l
• • Haemoglobin ≥8g/dL
• • Willing and able to comply with the requirements of the protocol, including contraceptive advice, where applicable
• • Written informed consent
• Exclusion Criteria:
• • Previous treatment for Hodgkin lymphoma, excluding short courses of oral corticosteroids at a dose of 100mg prednisolone (or equivalent) for up to 7 days
• • Infradiaphragmatic disease
• • Nodular lymphocyte predominant Hodgkin lymphoma
• • Absence of FDG-avid lesions on baseline PET scan
• • Age 70 years or over or age 15 years or under
• • Other cancer diagnosed with the last 5 years. Patients with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin are not excluded
• • Recurrent or persistent other cancer within last 5 years irrespective of date of initial diagnosis
• • Pre-existing grade ≥1 sensory or motor neuropathy from any cause
• • History of or current progressive multi-focal leukoencephalopathy or other chronic condition of the brain
• • Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
• • Infection with HIV, hepatitis C or active hepatitis B infection (surface antigen or DNA positive)
• • Any active systemic viral, bacterial or fungal infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first trial drug dose
• • Receiving or recently treated with any other investigational agent (within 4 weeks of trial entry)
• • Pregnant or breastfeeding women
• • Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD
• • Known history of any cardiovascular or respiratory conditions that would preclude anthracycline or bleomycin administration
• • Other significant medical or psychiatric comorbidity that in the opinion of the investigator would make administration of ABVD or A2VD hazardous