Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

• Status: Not yet recruiting
• Trial end date: 2032-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Eligible patients will be randomised to receive either ABVD or A2VD chemotherapy.

An interim PET-CT scan will be performed after 2 cycles of treatment, which will be used to adapt subsequent treatment. Patients will receive a total of 3-4 cycles of chemotherapy and may also receive involved site radiotherapy as consolidation.

Patients will be followed up for a minimum of 5 years after treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborators: Canadian Cancer Trials Group; Takeda
• Treatments: Bleomycin; Brentuximab Vedotin; Dacarbazine; Doxorubicin; Mitogens; Vinblastine

Criteria

Inclusion Criteria:

• Males and females aged 16-69 years (inclusive

• Histologically confirmed classical Hodgkin lymphoma

• Stage I or II 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

• 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

• 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