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

Sponsor
University College, London
Study ID
NCT05627115
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab, AVD, Radiotherapy — DRUG
    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.

Study Details

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

Key Dates

First listed
Nov 25, 2022
Start date
Mar 1, 2024
Status verified
Nov 2023
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tislelizumab Response-Adapted Treatment
    All patients will receive 3 cycles of tislelizumab 200 mg (IV) every 21 days. They will then undergo a PET-CT scan (PET1). Subsequent treatment with further tislelizumab, radiotherapy, and between 2-6 cycles of chemotherapy (Doxorubicin, Vinblastine, and Dacarbazine - AVD) is determined by the patient's stage and response at PET1.

Primary Outcome Measure

Two-year event-free survival (EFS) [ Time Frame: 2 years after start of treatment ]

Central Contacts

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