Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLi Zhiming
About this trial
This is a multi-center, phase II, prospective study. The main purpose of study is to evaluate the efficacy and safety of Glofitamab plus Polatuzumab vedotin and Zuberitamab in patients with newly diagnosed diffuse large B-cell lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent.
Age ≥18 years at the time of signing the Informed Consent Form
IPI score 2-5.
ECOG performance status of 0-2.
Disqualifiers
History of severe cardiac disease: New York Heart Association (NYHA) grade 3-4, congestive heart failure, myocardial infarction or cerebrovascular accident within the past 3 months, unstable arrhythmias, or unstable angina or history of multiple cardiovascular events) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm).
Patient with current or history of CNS lymphoma.
Patient with uncontrolled severe infection, whether bacterial (e.g., tuberculosis), viral (including, but not limited to severe pneumonia, COVID-19, Epstein-Barr virus [EBV], cytomegalovirus [CMV], hepatitis B, hepatitis C, and HIV], fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks prior to study enrollment.
Patient with current > Grade 1 peripheral neuropathy.
Trial design
Design model
Single group
Treatments tested in this trial
Glofitamab; Polatuzumab vedotin; Zuberitamab; Cyclophosphamide; Doxorubicin; Prednisone
DrugStep-up cycle (cycle 1) will comprise intravenous (i.v.) application of obinutuzumab 1,000 mg on D1, followed by i.v. application of polatuzumab vedotin 1.8 mg/kg on D2 and i.v. application of glofitamab in escalating doses of 2.5 mg on D8 and 10 mg on D15. Target dose phase (cycle 2-3) will comprise polatuzumab vedotin 1.8 mg/kg, i.v., glofitamab 30 mg i.v. and Zuberitamab 375mg/m2 i.v. on D1 and repeated Q3W. Adaptive treatment phase (cycle 4-9) will include two arms with dose cycle guided by PET/CT after C3: i.) If CR, it will comprise polatuzumab vedotin 1.8 mg/kg, i.v.(C4-6) on D1, glofitamab 30 mg i.v. (C4-8) on D2 and Zuberitamab 375mg/m2 i.v. (C4-8) on D1 and repeated Q3W. ii.) if PR or SD, it will comprise polatuzumab vedotin 1.8 mg/kg, i.v .(C4-6) on D1, glofitamab 30 mg i.v. (C4-8) on D8, Zuberitamab-CHP\[Zuberitamab 375mg/m2 i.v., cyclophosphamide i.v., doxorubicin i.v., and prednisone p.o. (C4-9)\] on D1 and repeated Q3W.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Trial groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CR rate at C4D1
CR rate, defined as the proportion of patients achieving complete remission at Cycle 4 Day 1.
Time frame
9 weeksSecondary outcomes
1
2-yr Progression-free survival (PFS) rate
PFS, defined as the time from first treatment to disease progression (PD) or relapse after complete remission (CR) as per Lugano Classification of 2014, or death due to any cause, whichever occurs first. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment.
Time frame
2 years follow-up after EOTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Li Zhiming
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov
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