A Randomised Phase III Trial With a PET Response Adapted Design Comparing ABVD +/- ISRT With A2VD +/- ISRT in Patients With Previously Untreated Stage IA/IIA Hodgkin Lymphoma (RADAR)

  • STATUS
    Recruiting
  • End date
    Sep 22, 2032
  • participants needed
    1042
  • sponsor
    University College, London
Updated on 22 September 2022
lymphoma
ejection fraction
doxorubicin
chemotherapy regimen
bleomycin
dacarbazine
vinblastine
brentuximab
classical hodgkin lymphoma

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.

Description

Eligible patients will be randomised to receive either ABVD chemotherapy (doxorubicin, bleomycin, vinblastine and dacarbazine) or A2VD chemotherapy (doxorubicin, brentuximab vedotin, vinblastine and dacarbazine, with growth factor support).

If patients agree, they will have a PET-CT scan after 1 cycle (PET1). The result of this scan will be blinded and used for exploratory endpoints only. Treatment will not be influenced by the result of this scan.

All patients will have a PET-CT scan after 2 cycles of treatment (PET2) which will be centrally reviewed. The Deauville score from central review will be used to risk adapt subsequent therapy as follows:

  • Patients with Deauville score 1-3 will have one further cycle of their randomised chemotherapy and then enter follow up.
  • Patients with Deauville score 4 will have two further cycles of their randomised chemotherapy followed by involved site radiotherapy
  • Patients with Deauville score 5 will be withdrawn from trial treatment. They will have further treatment at their treating clinician's discretion and will enter follow up for the trial.

Patients with Deauville score 4 on PET2 will have a final PET-CT scan to confirm adequate treatment response.

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

Details
Condition Hodgkin Lymphoma
Treatment Bleomycin, doxorubicin, dacarbazine, brentuximab vedotin, Vinblastine, Involved site radiotherapy, Haematopoietic growth factor
Clinical Study IdentifierNCT04685616
SponsorUniversity College, London
Last Modified on22 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females aged 16-69 years (inclusive
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
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