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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03617666




Registration number
NCT03617666
Ethics application status
Date submitted
20/07/2018
Date registered
6/08/2018

Titles & IDs
Public title
Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study
Scientific title
AVENuE - Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study
Secondary ID [1] 0 0
2018-002227-42
Secondary ID [2] 0 0
UCL /17/0192
Universal Trial Number (UTN)
Trial acronym
AVENuE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelumab

Experimental: Avelumab - Patients with newly diagnosed cHL will receive single agent avelumab in 2 cycles


Treatment: Drugs: Avelumab
Patients with newly diagnosed cHL will receive 4 doses of single agent avelumab 10 mg/kg intravenously given every 2 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate
Timepoint [1] 0 0
2 months (after first dose of avelumab)
Secondary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
1 year and 3 years (from date of registration)
Secondary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
1 year and 3 years (from date of registration)
Secondary outcome [3] 0 0
Rates of adverse events with avelumab
Timepoint [3] 0 0
3 months (after first dose of avelumab)
Secondary outcome [4] 0 0
Rates of adverse events with ABVD/BEACOPP
Timepoint [4] 0 0
7 months (after commencing ABVD/BEACOPP)
Secondary outcome [5] 0 0
Complete metabolic response rate
Timepoint [5] 0 0
2 months (after commencing ABVD)
Secondary outcome [6] 0 0
Partial metabolic response rate
Timepoint [6] 0 0
2 months (after commencing ABVD)
Secondary outcome [7] 0 0
Treatment compliance
Timepoint [7] 0 0
9 months (from the date of registration)

Eligibility
Key inclusion criteria
* Previously untreated classical Hodgkin lymphoma
* High risk stage II (defined as stage IIB, presence of bulky disease, 3 or more sites of disease), stage III or IV as assessed by FDG-PET/CT
* ECOG performance status 0-1
* Adequate bone marrow function (Hb >80g/l, Platelets >75 x 10^9/l, neutrophils >1.0 x 10^9/l)
* Adequate liver function tests (ALT/AST <2.5 x ULN, total serum bilirubin level <1.5 x ULN)
* Creatinine clearance >50ml/min calculated by Cockroft-Gault formula
* Written informed consent
* Willing to comply with the contraceptive requirements of the trial
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Nodular lymphocyte predominant Hodgkin lymphoma
* Compressive symptoms due to disease (which may or may not be bulky). If there is evidence of compression of vital structures radiologically but the patient is asymptomatic, the case must be discussed with the TMG.
* 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 excluding patients with vitiligo, diabetes mellitus type 1, hypo- and hyperthyroidism, coeliac disease not requiring immunosuppressive therapy
* Immunosuppressive therapy within the last 2 months, apart from inhaled, intranasal, topical corticosteroids or systemic corticosteroids at low doses (=10mg prednisolone per day or equivalent - see steroid exception below)
* Prior history of solid organ or allogeneic haematopoietic stem cell transplant
* Positive serology for hepatitis B or C (unless due to vaccination), or hepatitis C RNA negative if hepatitis C antibody positive
* Known HIV infection
* Administration of a live vaccine within 30 days prior to study entry
* History of allergy to monoclonal antibodies, anaphylaxis or uncontrolled allergy
* Chemo- or radiotherapy within 15 days prior to registration. Corticosteroids permitted for disease control but must be weaned down to =10mg prednisolone per day or equivalent at least 7 days prior to starting avelumab - steroids may only be started for disease control after the baseline PET-CT
* Persisting toxicity (of >grade 1) related to prior therapy, however, alopecia, sensory neuropathy Grade <2, or other grade <2 not constituting a safety risk based on investigator's judgement are acceptable
* Major surgery within 4 weeks prior to registration
* Active infection requiring systemic therapy
* Myocardial infarction, unstable angina, coronary artery bypass graft, cerebrovascular accident or transient ischaemic attack within the past 6 months
* Non-haematological malignancy within the past 3 years (some exceptions apply)
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
- Heidelberg
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Birmingham
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Glasgow
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Leicester
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Manchester
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Norwich
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Oxford
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Plymouth
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Stoke
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Other
Name
University College, London
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Graham Collins
Address 0 0
Churchill Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03617666