Camrelizumab in Combination With Apatinib in Refractory and Relapsed DLBCL
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|ClinicalTrials.gov Identifier: NCT04476459|
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : July 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Camrelizumab Drug: Apatinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 23, 2020|
|Estimated Primary Completion Date :||August 1, 2022|
|Estimated Study Completion Date :||August 1, 2023|
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
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.
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.
- Overall Response Rate (ORR), Investigator-Assessed [ Time Frame: upto 24 months ]Overall response was determined on the basis of investigator assessments according to lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016. Tumor assessments were performed with CT/MRI with or without PET.
- The optimal dosage of apatinib combined with camrelizumab [ Time Frame: up to 6 months ]Maximum tolerable dose（MTD）and dose-limiting toxicity（DLT）of Toripalimab will be conducted in Phase Ib clinical studies. MTD and DLT is defined as protocol-defined Toripalimab related events.
- Progression-free Survival [ Time Frame: up to 36 months ]The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
- Overall Survival [ Time Frame: up to 36 months ]Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason
- Duration of Response [ Time Frame: up to 36 months ]The time from the first assessment of CR or PR to PD (progressive disease) or death from any cause
- Time To Progression [ Time Frame: up to 36 months ]Time from randomization to PD
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to 36 months ]An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476459
|Contact: Huiqiang Huang, Professor||+86 020 firstname.lastname@example.org|
|Department of Medical Oncology, Sun Yat-sen University Cancer Center,||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: HuiQiang Huang 86-020-87343350 email@example.com|