The CTC offices are currently closed for refurbishment. Access to trial TMFs and patient records will be limited during this period. We will still be able to receive post during this time, but there may be a small delay in responding to this. Our fax lines may also be subject to disruption. Where possible, please direct all correspondence via email to trial-specific email addresses. We appreciate your patience and understanding.

Due to COVID-19 and current government guidance, UCL CTC staff continue to work remotely with limited access to the office. Please continue to email the trial specific mailbox with any urgent queries. For paper CRF trials, please continue to copy and scan CRFs to the trial inboxes (remove all patient identifiers except Trial Number and Initials) until further notice.

 
Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
27/09/2019
Funder:
Pfizer Limited
Sponsor:
UCL
Chief Investigator:
Graham Collins
Recruitment target:
47
EudraCT number:
2018-002227-42
Contact details:
ctc.avenue@ucl.ac.uk
Lay summary:
AVENuE
Avelumab in the frontline treatment of advanced classical Hodgkin lymphoma - a window study
Description
Design: AVENuE is a non-randomised, single arm Phase II trial investigating how patients with newly diagnosed, untreated advanced classical Hodgkin lymphoma respond to treatment with the monocolonal antibody, avelumab. 

Treatment:

All patients will start treatment by receiving 2 cycles of the monoclonal antibody, avelumab, this will last about 2 months. Patients will have a PET-CT scan after these 2 cycles to assess their response to treatment. 

Patients will then go on to receive standard treatment for Hodgkin lymphoma which is a response adapted approach whereby all patients receive 2 cycles of ABVD chemotherapy followed by an interim PET scan. For those with a negative PET result (which shows the patient has responded well to treatment), 4 cycles of AVD chemotherapy are given. Patients with a positive PET result (which shows the patients has not responded as well to treatment) go on to receive BEACOPP chemotherapy. 


Key inclusion/exclusion criteria:

Key Inclusion Criteria

• Aged 16-60 (inclusive)

• Previously untreated classical Hodgkin lymphoma

• High risk stage II, stage III or IV disease

• ECOG performance status 0-1

• Adequate bone marrow and liver function 

Key Exclusion Criteria

• Nodular lymphocyte predominant Hodgkin lymphoma

• Requirement for urgent treatment due to life-threatening complications of the disease

• Women who are pregnant or breastfeeding

• History of colitis, inflammatory bowel disease or pneumonitis

• Patients with autoimmune disorders (some exclusions apply)

• Positive serology for hepatitis B or C 

• Known HIV infection

• Major surgery within 4 weeks prior to registration

• Active infection requiring systemic therapy

• Non-haematological malignancy within the past 3 years 

• Previously treated haematological malignancy

• Any uncontrolled medical condition which can impair delivery of planned immunochemotherapy

• Patient not deemed suitable for ABVD/AVD/escalated-BEACOPP/BEACOPP-14

Duration of recruitment: 1 year
Aim
To determine the overall response rate to single agent avelumab in a previously untreated fit population of advanced classical Hodgkin lymphoma.
To establish the safety of delivering an ABVD-based regimen following single agent avelumab.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

View map
Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

Copyright © 2021 UCL | Disclaimer | Freedom of Information | Accessibility | Privacy | Cookies | Contact Us