Trials / Unknown
UnknownNCT04796857
Tislelizumab in Combination With Lenalidomide in Refractory and Relapsed Elderly Patients With Non-GCB DLBCL
Tislelizumab in Combination With Lenalidomide in in Patients With Relapsed or Refractory Elderly Patients With Non-GCB Diffuse Large B Cell Lymphoma: a Prospective Phase Ib/II, Multicentre, Open-label, Single-arm Trial
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Huiqiang Huang · Academic / Other
- Sex
- All
- Age
- 60 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Aim of this study will evaluate the efficacy and safety of tislelizumab in combination with lenalidomide in in patients with relapsed or refractory Elderly Patients with non-GCB Diffuse Large B Cell Lymphoma
Detailed description
Elderly patients with relapsed /refractory non-GCB diffuse large B cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully or tolerated the conventional chemotherapy. Lenalidomide has a unique therapeutic effect in Non-GCB DLBCL. Some studies have shown that the combination of lenalidomide and PD-1 antibody shows a synergistic effect in the exploration of DLBCL, and the patients are well tolerated.The investigators will evaluate the efficacy and safety of tislelizumab in combination with lenalidomide in the elderly patients with relapsed refractory non-GCB DLBCL failed from second line chemotherapy.
Conditions
- Non-GCB/ABC Diffuse Large B-Cell Lymphoma
- High-grade B-cell Lymphoma
- Follicular Lymphoma Grade IIIb
- Transformed Lymphoma
- EBV-Positive DLBCL, Nos
- ALK-Positive Anaplastic Large Cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PD-1 Antibody | Tislelizumab will be administered every 4 weeks up to 6 cycles during induction phase if patients get CR or PR after induction phase. |
| DRUG | Lenalidomide | Phase I: dose escalation phase. Patients will oral dosage as 10mg, 20mg, per day. Aim to evaluate MTD and DLT, RP2D. Phase II：Patients continuous oral lenalidomide as RP2D up to 6 cycles during induction phase |
Timeline
- Start date
- 2021-03-31
- Primary completion
- 2023-03-31
- Completion
- 2023-03-31
- First posted
- 2021-03-15
- Last updated
- 2021-03-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04796857. Inclusion in this directory is not an endorsement.