POLA-R-CHP in the First-line Treatment of Transformed DLBCL
ConditionTransformed Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
This study aims to evaluate efficacy and safety of POLA-R-CHP in the treatment of patients with transformed DLBCL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 -80 years old;
Histologically confirmed transformed DLBCL;
ECOG 0-2;
Signed informed consent form.
Disqualifiers
Individuals who are allergic to human or mouse monoclonal antibodies, or known sensitivity or allergic reaction to murine products;
Previous organ transplantation;
Prior treatment of any condition (e.g., cancer, rheumatoid arthritis) with cytotoxic drugs within 5 years at the time of screening or prior use of any anti-CD20 antibodies;
Evidence of uncontrolled significant comorbidities that may affect the patient's compliance with the study protocol or affect the interpretation of the study results, including significant cardiovascular disease (such as New York College of Cardiology Class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmia, or unstable angina) or pulmonary disease (including history of obstructive pulmonary disease and bronchospasm);
Trial design
Design model
Single group
Treatments tested in this trial
POLA-R-CHP
DrugPola-R-CHP is a combination of rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year progression-free survival (PFS) assessed by imaging examination
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
Time frame
From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 yearsSecondary outcomes
1
complete remission rate assessed by imaging examination
the ratio of numbers of patients with complete response after 6 treatment cycles to all the participants
Time frame
up to 6 months2
2-year event-free survival (EFS)
the period from the date of patients sign informed consent to the observed event for any reason
Time frame
From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years3
2-year overall survival rate
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Time frame
From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years4
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
Through study completion, up to 2 yearsOther outcomes
1
tissue biomarkers
Detection of tissue DNA biomarkers in the treatment of transformed diffuse large B cell lymphoma
Time frame
Throughout the treatment period, up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov