Glofitamab in Chinese Patients With R/R DLBCL
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital
About this trial
This study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically-confirmed DLBCL
Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy
Participants must have measurable disease
Disqualifiers
Pregnancy or breastfeeding
Patient with known active infection, or reactivation of a latent infection
Patient with active autoimmune disease or immune deficiency
severe organ failure：LVEF<40%；DLCO<40%；eGFR<30ml/min；Bilirubin≥3ULN
Trial population
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Glofitamab
DrugGlofitamab given in standard dosage
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: treatment group1 intervention
Trial outcomes
Primary outcomes
1
PFS
Progression-free survival
Time frame
1 yearSecondary outcomes
1
OS
overall survival
Time frame
2 year2
CR rate
complete response
Time frame
6 weeks, 18 weeks, 36 weeks3
ORR
overall response rate
Time frame
6 weeks, 18 weeks, 36 weeks4
DOR
duration of response
Time frame
2 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov