Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

Part of paid clinical trials in Stanford, California.

Sponsor
University College, London
Study ID
NCT04685616
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Involved site radiotherapy — RADIATION
    Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines. Recommended dose 30Gy
  • Doxorubicin — DRUG
    See arm description
  • Bleomycin — DRUG
    See arm description
  • Brentuximab vedotin — DRUG
    See arm description
  • Vinblastine — DRUG
    See arm description
  • Dacarbazine — DRUG
    See arm description
  • Haematopoietic growth factor — DRUG
    See arm description

Study Details

RADAR is a multicentre, international, randomised, open-label phase III clinical trial composed of 2 trials running in parallel. Trial 1 will be led and sponsored by University College London (UCL) and conducted in Europe and Australia/New Zealand. Trial 2 will be led by the Canadian Cancer Trials Group (CCTG) and conducted in North America, with CCTG the regulatory sponsor in Canada, and University of Miami the regulatory sponsor and IND holder in the US. Datasets from Trial 1 and Trial 2 will be combined to achieve the total sample size. Data analysis will be performed by UCL and therefore UCL is responsible for the clinicaltrials.gov entry. 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.

Key Dates

Start date
Apr 14, 2022
Status verified
Mar 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2032

Study Design

Enrollment
1,042 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ABVD +/- ISRT
    2 x 28 day cycles of ABVD: Doxorubicin 25mg/m\^2 IV days 1 \& 15 Bleomycin 10000 IU/m\^2 days 1 \& 15 Vinblastine 6mg/m\^2 days 1 \& 15 Dacarbazine 375mg/m\^2 days 1 \& 15 PET-CT after 2 cycles will determine subsequent treatment: Deauville score 1-3 (PET CMR): 1 further cycle of ABVD then follow up Deauville score 4 (PET positive): 2 further cycles of ABVD followed by involved site radiotherapy (ISRT) Deauville score 5: withdraw from trial treatment; further treatment will be given at the treating clinician's discretion. Enter follow up for the trial.
  • Experimental: A2VD +/- ISRT
    2 x 28 day cycles of A2VD: Doxorubicin 25mg/m\^2 IV days 1 \& 15 Brentuximab vedotin 1.2mg/kg (max 120mg) days 1 \& 15 Vinblastine 6mg/m\^2 days 1 \& 15 Dacarbazine 375mg/m\^2 days 1 \& 15 Filgrastim (or equivalent haematopoietic growth factor) for 5-7 days from day 2 and day 16 (or single dose of peg-filgrastim on days 2 \& 16) PET-CT after 2 cycles will determine subsequent treatment: Deauville score 1-3 (PET CMR): 1 further cycle of A2VD then follow up Deauville score 4 (PET positive): 2 further cycles of A2VD followed by involved site radiotherapy (ISRT) Deauville score 5: withdraw from trial treatment; further treatment will be given at the treating clinician's discretion. Enter follow up for the trial.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 3 years from end of treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford University - (Stanford Cancer Institute)StanfordCalifornia94305
Austin Yeung
Ranjana Advani (PRINCIPAL_INVESTIGATOR)
University of Miami School of MedicineMiamiFlorida33136
Safia Sawleh
Craig Moskowitz (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Pamela Park
Alison Moskowitz (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University - (Stanford Cancer Institute)· Stanford, CAUniversity of Miami School of Medicine· Miami, FLMemorial Sloan Kettering Cancer Center· New York, NY

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