Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
To evaluate the efficacy and side effects of Zanubrutinib combined with Obinutuzumab (ZO) in the treatment of newly diagnosed follicular lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥18 years old and gender-neutral;
Follicular lymphoma definitively diagnosed according to the REAL/WHO classification, stage II-IV requiring treatment according to the GELF code;
ECOG score 0-2;
Lymphoma efficacy evaluation criteria using Lugano 2014 Lymphoma must have at least one measurable or evaluable lesion: signed informed consent, subjects recruited based on inclusion and
Disqualifiers
HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) Enrollment only if HBV-DNA test is negative;
Normal major organ function: liver function serum bilirubin ≤ 2.0 × ULN , serum ALT and AST ≤ 2.5 × ULN, renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma);
Informed consent (patients must sign an informed consent form for all studies).
Medically significant CNS lymphoma or molluscum contagiosum or large cell transformation;
Trial design
Design model
Single group
Treatments tested in this trial
Zanubrutinib combined with Obinutuzumab
DrugZanubrutinib combined with Obinutuzumab (ZO), a specific dose on specific days.
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: Zanubrutinib (Z) combined with Obinutuzumab (O)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CR
Complete remission rate
Time frame
up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital of Xiamen University
Lead sponsor
Shanxi Province Cancer Hospital
Collaborator
The First Hospital of Jilin University
Collaborator
Fujian Cancer Hospital
Collaborator
Jiangxi Provincial Cancer Hospital
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator
Sun Yat-sen University
Collaborator
Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov