Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
13/01/2025
Funder:
BeiGene Switzerland GmbH
Sponsor:
UCL
Chief Investigator:
Prof Graham Collins
Recruitment target:
40
EudraCT number:
2022-003677-37
Contact details:
ctc.ratify@ucl.ac.uk
Note: For enquiries only. DO NOT use for clinical referrals.
Lay summary:
RATiFY
Response Adapted incorporation of Tislelizumab into the Front-line treatment of older patients with advanced stage Hodgkin lYmphoma
Description
Design:
A phase II, multicentre, non-randomised, open label study.
Treatment:
All patients will receive 3 cycles of tislelizumab which will be administered at a dose of 200 mg (IV) on day 1 of each 21-day cycle. Patients will then undergo a PET-CT with ceCT scan (PET1). Subsequent treatment is determined by the patient’s response to tislelizumab (as determined by PET1). Patients who are in complete metabolic response (CMR) at PET1 will receive 4 cycles of tislelizumab and AVD therapy. Patients who do not attain CMR will receive 6 cycles of tislelizumab and AVD therapy.
Key inclusion/exclusion criteria:
Inclusion:
1. Newly diagnosed untreated classic Hodgkin lymphoma
2. Age 60 years or over
3. Advanced stage defined as: stage IIB with bulk or E-lesions, stage III or stage IV based on PET-CT assessment. Bulk is defined as any lesion ≥ 10cm or a mediastinal mass ≥ 1/3 of the thoracic diameter measured at T5/T6
4. In the view of the investigator, fit for combination chemotherapy (includes those who would require planned dose reduction although no lower than 50% doxorubicin)
5. Written informed consent
6. Measurable disease on contrast-enhanced CT as defined by Cheson et al., 2014 (Nodal lesion of longest diameter 1.5 cm or extranodal lesion of longest diameter 1.0 cm)
7. FDG avid disease on baseline 18 FDG-PET-CT scan
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 
9. Adequate bone marrow function (Platelets ≥ 75 x 109/L without platelet transfusion for 72 hours, Neutrophils ≥ 1.0 x 109/L without G-CSF for 7 days)
10. Adequate liver function tests (ALT / AST ≤ 2.5 x ULN, total serum bilirubin ≤1.5 x ULN)
11. Creatinine Clearance ≥ 30 ml/min as defined by the Cockroft-Gault equation
12. Adequate cardiac function as determined by a transthoracic echocardiogram or multiplanar gated radionuclide cardiac angiography (MUGA) demonstrating left ventricular ejection fraction is ≥ 50% and confirming the absence of severe valvular heart disease
13. Willing to comply with the contraceptive requirements of the trial
14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Duration of recruitment: 2 years
Aim
To demonstrate that the incorporation of tislelizumab in a response adapted approach to the front-line treatment of older patients with advanced stage Hodgkin lymphoma is safe, tolerable, and results in acceptable event-free survival (EFS).
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
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