Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04685616
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2020-11-27
Brief Title:
Brentuximab Vedotin in Early Stage Hodgkin Lymphoma
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
A Randomised Phase III Trial With a PET Response Adapted Design Comparing ABVD - ISRT With A2VD - ISRT in Patients With Previously Untreated Stage IAIIA Hodgkin Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADAR
Brief Summary:
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 AustraliaNew 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 clinicaltrialsgov 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
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
Detailed 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 clinicians 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
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 clinicians 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB number 20230081 | OTHER | University of Miami | None |
| 2020-005160-65 | EUDRACT_NUMBER | None | None |
| IISR X25041 | OTHER_GRANT | None | None |
| UCL150105 | OTHER | None | None |
| CCTG HD12 | OTHER | None | None |