HD12

HD12 Details
Status: Open
Activation Date: 2023AUG08
Phase: III

Description: A Randomized 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)

Eligibility: Patients, 16-69 years old and have histologically confirmed stage I or II classical Hodgkin lymphoma with no mediastinal bulk disease or B symptoms. Patients must have ECOG status of 0 to 2.with no prior treatment for Hodgkin lymphoma, but are fit to receive anthracycline-based chemotherapy. Patient must have the following lab values: creatinine clearance >40 ml/min, total bilirubin <1.5 x ULN, ALT or AST <2 x ULN, haemoglobin > or equal to 8g/dL, neutrophils > or equal to 1.0 x109/l, and platelets > or equal to 100 x109/l. Patients may not have nodular lymphocyte Hodgkin lymphoma, pre-existing grade > or equal to 1 sensory or motor peripheral neuropathy, symptomatic neurologic disease, history of progressive PML, significant cardiovasular or respiratory disease, serious active disease or co-morbid medical condition, uncontrolled active systemic infection, HIV, hepatitis C, or active hepatitis B. No other cancer (with exception), recurrent, or persistent cancer within last 5 years.

Objective: Primary objective: To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) improves progression free survival (PFS) Secondary objectives: To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) improves PET CMR rates To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) improves event-free survival (EFS) To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) has an effect on overall survival (OS)

Participation: Open to member centres

Lay Description: The HD.12/RADAR study is for patients diagnosed with previously untreated stage IA/IIA Hodgkins Lymphoma. The purpose of the study is to answer the following question: Will replacing one of the drugs in the usual treatment with a drug called brentuximab vedotin a) improve cure rates and/or b) reduce side effects during treatment and later in life?

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Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
HEMATOLOGIC	HD12	Open Trial	0	2	2

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(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
HEMATOLOGIC	HD12	Open Trial	0	0

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Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
HEMATOLOGIC	HD12	Open Trial	0	0	0	0	0	0	0	0