NCT04476459

Camrelizumab in Combination With Apatinib in Refractory and Relapsed DLBCL

Camrelizumab in Combination With Apatinib in in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma: a Phase Ib/II, Multicentre, Open-label, Single-arm Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Huiqiang Huang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of camrelizumab in combination with apatinib in in patients with relapsed or refractory diffuse large B cell lymphoma failed from second line chemotherapy.

Detailed description

Patients with relapsed /refractory diffuse large B cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. Apatinib is a new type of oral tyrosine kinase inhibitor targeting VEGFR-2. Some studies have shown that the combination of low-dose apatinib and camrelizumab shows a synergistic effect in the exploration of multiple solid tumors, and the adverse reactions of low-dose apatinib are significantly reduced, and the patients are well tolerated.The investigators will evaluate the efficacy and safety of camrelizumab in combination with apatinib in the patients with relapsed refractory diffuse large B cell lymphomafailed from second line chemotherapy.

Conditions

• 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	Camrelizumab	Camrelizumab will be administered every 3 weeks up to 6 cycles during induction phase, and then every 4 weeks up to 12 cycles in maintenance phase if patients get CR or PR after induction phase.
DRUG	Apatinib	Phase I: dose escalation phase. Patients will oral dosage as 250mg, 500mg or 750mg,qd, per day. Aim to evaluate MTD and DLT, RP2D. Phase II：Patients continuous oral apatinib as RP2D up to 6 cycles during induction phase, and then 250mg/d up to 1 year in maintenance phase if patients get CR or PR after induction phase.

Timeline

• Start date: 2020-07-23
• Primary completion: 2022-08-01
• Completion: 2023-08-01
• First posted: 2020-07-20
• Last updated: 2021-03-15

Locations

1 site across 1 country: China