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NOT YET RECRUITING
NCT05627115
PHASE2

Response Adapted Incorporation of Tislelizumab Into the Front-line Treatment of Older Patients With Hodgkin lYmphoma

Sponsor: University College, London

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the effect of tislelizumab treatment in patients with Hodgkin lymphoma. The main question it aims to answer is whether including a drug called tislelizumab in first-line treatment of Hodgkin lymphoma for patients age 60 years and older is effective and well-tolerated. Participants will initially receive tislelizumab infusion every 21 days for 3 doses. After this a PET scan will be performed to assess the response. The subsequent treatment patients receive will depend on the following factors: 1. The lymphoma stage (early stage or advanced stage) 2. The presence or absence of specific high-risk features at the time of diagnosis 3. How well the lymphoma responds to the initial 3 doses of tislelizumab

Official title: Response Adapted Incorporation of Tislelizumab Into the Front-line Treatment of Older Patients With Hodgkin lYmphoma (RATiFY)

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-03-01

Completion Date

2028-10-01

Last Updated

2023-11-29

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab, AVD, Radiotherapy

GROUP A: Early stage disease without adverse features in CMR: 2 further cycles tislelizumab then radiotherapy then 200mg IV tislelizumab once every 3 weeks until a maximum of 2 years total treatment. PET-CT (PET2) 12 weeks after radiotherapy. GROUP B: Early stage disease with adverse features in CMR: 2 cycles of AVD plus tislelizumab then radiotherapy. PET-CT (PET2) 12 weeks after the completion of radiotherapy. GROUP C: All early stage disease not in CMR: 4 cycles of AVD plus tislelizumab then PET-CT and radiotherapy. PET-CT 12 (PET2) weeks after radiotherapy. GROUP D: Advanced stage disease in CMR: 4 cycles of AVD plus tislelizumab then radiotherapy at investigator's discretion. PET-CT (PET2) 12 weeks after radiotherapy. GROUP E: Advanced stage disease not in CMR: 6 cycles of AVD plus tislelizumab then PET-CT then radiotherapy at investigator's discretion. PET-CT (PET2) 12 weeks after radiotherapy.