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Monoclonal Antibodies

Brentuximab Vedotin for Hodgkin Lymphoma (RADAR Trial)

Phase 3
Recruiting
Led By John Radford
Research Sponsored by University College, London
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0-2
No previous treatment for Hodgkin lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years from end of treatment
Awards & highlights

RADAR Trial Summary

This trial aims to compare the efficacy and safety of 2 chemotherapy regimens for treating advanced Hodgkin lymphoma. Patients will receive 3-4 cycles of chemo & may get radiation. Data from 2 trials will be combined & followed up for 5 yrs.

Who is the study for?
This trial is for individuals aged 16-69 with early stage Hodgkin lymphoma who haven't had treatment before. They must be physically fit, have normal organ function, and agree to follow the study's rules including contraceptive advice. Excluded are those allergic to trial drugs, pregnant or breastfeeding women, over age 70 or under age 15, with certain infections or other serious health issues.Check my eligibility
What is being tested?
The RADAR trial tests ABVD versus A2VD chemotherapy regimens in patients with Hodgkin lymphoma. It includes an interim PET-CT scan after two cycles of chemo to adjust further treatment. Participants may also receive radiotherapy and will be followed up for at least five years post-treatment.See study design
What are the potential side effects?
Chemotherapy can cause side effects like nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, heart problems from anthracyclines (like doxorubicin), lung issues from bleomycin and nerve damage from brentuximab vedotin.

RADAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I have not received any treatment for Hodgkin lymphoma.
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My blood tests show enough neutrophils and platelets.
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My diagnosis is classical Hodgkin lymphoma.

RADAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years from end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years from end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Event-free survival (EFS)
Incidence of second cancers and cardiovascular disease
Overall survival (OS)
+2 more
Other outcome measures
Change in pulmonary function tests at end of treatment, 1 and 2 years
Correlation between maximum tumour dimension at baseline and end of treatment with PFS
Prognostic and predictive power of baseline PET features
+1 more

RADAR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: A2VD +/- ISRTExperimental Treatment6 Interventions
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.
Group II: ABVD +/- ISRTActive Control5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Brentuximab vedotin
2012
Completed Phase 2
~200
Vinblastine
1998
Completed Phase 3
~5260
Dacarbazine
2005
Completed Phase 3
~5110

Find a Location

Who is running the clinical trial?

University College, LondonLead Sponsor
843 Previous Clinical Trials
38,912,355 Total Patients Enrolled
TakedaIndustry Sponsor
1,209 Previous Clinical Trials
4,186,840 Total Patients Enrolled
University of MiamiOTHER
913 Previous Clinical Trials
410,676 Total Patients Enrolled
~695 spots leftby Sep 2030
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