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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
834 Previous Clinical Trials
38,909,357 Total Patients Enrolled
TakedaIndustry Sponsor
1,203 Previous Clinical Trials
4,176,902 Total Patients Enrolled
University of MiamiOTHER
902 Previous Clinical Trials
409,034 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 25 years or older accepted into this trial?

"This research study is seeking participants aged sixteen and older, up to sixty nine years old."

Answered by AI

To what conditions is A2VD +/- ISRT commonly prescribed?

"A2VD in combination with or without ISRT has the capacity to treat acute myeloid leukemia, neuroblastoma (nb), and pheochromocytomas."

Answered by AI

Could I feasibly enroll in this investigation?

"Eligibility criteria for this trial necessitates that patients must have been diagnosed with Hodgkin's lymphoma and be between 16 to 69 years old. This clinical trial is aiming to recruit approximately 1042 participants."

Answered by AI

Are there numerous sites in Canada participating in this experiment?

"This clinical trial is actively signing up participants from 24 sites scattered across the globe, including Miami, Adelaide and Box Hill. To make participating more convenient for you, it's best to select a site that is closest to your location."

Answered by AI

Has this trial been previously attempted in the past?

"Initially studied in 1997, A2VD +/- ISRT was sponsored and completed by Alfacell. After the initial trial of 300 patients in 1997, Phase 3 drug approval was granted for this medication. As of today there are 505 active studies ongoing across 2195 cities and 69 nations."

Answered by AI

Has research been conducted into the collaboration between A2VD and ISRT in the past?

"A2VD +/- ISRT was first explored at Klinikum Rechts Der Isar - Technische Universitaet Muenchen in 1997, resulting in 1368 concluded trials. As of now, 505 more investigations are actively occurring with many taking place at medical centres located in Miami and Newcastle."

Answered by AI

Are there still vacancies available in this study for participants?

"Correct. Data hosted on clinicaltrials.gov affirms that this medical study, posted initially on April 14th 2022, is currently seeking participants. 1042 individuals must be recruited from 24 different trial venues."

Answered by AI

What is the capacity of participants for this research study?

"Affirmative. Clinicaltrials.gov holds records that demonstrate this clinical trial is actively recruiting patients, having first been advertised on April 14th 2022 and most recently updated on September 22nd 2023. In total, 1042 participants need to be recruited from 24 different medical centres for the study's completion."

Answered by AI

Has the combination of A2VD and ISRT been validated for use by the Food and Drug Administration?

"Our team at Power has assessed A2VD +/- ISRT to be safe, rating it a 3 on our 1-3 scale. This is due to the accumulated evidence of its efficacy and safety gained from Phase 3 trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Brentuximab Vedotin in Early Stage Hodgkin Lymphoma
2022. "Brentuximab Vedotin in Early Stage Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04685616.
~695 spots leftby Sep 2030
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