Camrelizumab in Combination With Apatinib in Refractory and Relapsed DLBCL

Sponsor
Huiqiang Huang
Study ID
NCT04476459
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • ALK-Positive Anaplastic Large Cell Lymphoma
  • Diffuse Large B Cell Lymphoma
  • EBV-Positive DLBCL, Nos
  • Follicular Lymphoma Grade IIIb
  • High-grade B-cell Lymphoma
  • Transformed Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    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.
  • Apatinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 23, 2020
Status verified
Mar 2021
Primary completion
Aug 1, 2022
Completion
Aug 1, 2023

Study Design

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

Arms

  • Experimental: camrelizumab in combination with apatinib
    Apatinib should be given at a fixed time. On the day of camrelizumab infusion, Apatinib should be taken 30 minutes after the end of camrelizumab infusion

Primary Outcome Measure

Overall Response Rate (ORR), Investigator-Assessed [ Time Frame: upto 24 months ]

Central Contacts

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