NCT05627115

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Detailed description

Trial patients who are deemed eligible for the trial 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 scan (PET1). Subsequent treatment is determined by the patient's stage and response to tislelizumab (as determined by PET1). Patients with early stage lymphoma and no high-risk features who respond very well to the initial 3 doses of tislelizumab will receive a further 2 doses of tislelizumab, followed by radiotherapy, followed by tislelizumab once every 21 days for up to 2 years. All other patients will receive a combination of tislelizumab with chemotherapy for between 2 and 6 cycles. Each cycle will last 28 days. Tislelizumab will be given on day 1 and chemotherapy (doxorubicin (also known as Adriamycin), vinblastine and dacarbazine, or AVD) will be given on days 1 and 15, as injections or infusions into a vein. Following this some patients may require radiotherapy depending on their response to treatment. Patients who are in complete metabolic response (CMR) at PET1 will receive 2 fewer cycles of tislelizumab and AVD therapy than those not in CMR. A further 1 or 2 PET scans will be performed to assess how well the lymphoma has responded to the trial treatment, depending on the results of previous scans. After completing the treatment patients will then be followed-up for at least 2 years from the start of their participation in the trial. Note: Initial patients will be recruited to a safety run in. Once 6 evaluable patients have completed 2 cycles of tislelizumab and AVD after PET1 the independent data monitoring committee (IDMC) will review the data, and if considered tolerable, recruitment will continue to the full sample size (80 patients).

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2022-11-25
• Last updated: 2023-11-29