Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05627115 | Response Adapted Incorporation of Tislelizumab Into the Front-line Treatment of Older Patients With Hodgkin lYmphoma | PHASE2 | NOT YET_RECRUITING | 80 | — | — | Mar 1, 2024 | Oct 1, 2028 | Nov 29, 2023 | - | — |
To determine the effect of tislelizumab on 2 year EFS using a response-adapted approach to treatment in the front-line treatment of older patients with Hodgkin lymphoma
| Arm | Type | Description |
|---|---|---|
| Tislelizumab Response-Adapted Treatment | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: 1. Newly diagnosed untreated classic Hodgkin lymphoma (Stage I-IV) 2. Age 60 years or over 3. In the view of the investigator, fit for combination chemotherapy (includes those who would require planned dose reduction although no lower than 50% doxorubicin) 4. Written informed co...