diffuse large B-cell lymphoma
Conditions
Interventions
interventional group:polatuzumab vedotin plus obinutuzumab and dose-adjusted GDP (PG-DA-GDP), include: polatuzumab vedotin (Pola, 1.8mg/kg day1), obinutuzumab (G, 1000mg day1), gemcitabine (G, 1000mg/
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed diffuse large B-cell lymphoma (DLBCL) by 2 pathologists independently (2) Age = 18 years old and < 60 years old, or age = 60 years and = 75 years old, fit for standard-dose immunochemotherapy and ASCT, and defined as: IADL score of 8, serum albumin = 3.4 g/dl, and Charlson comorbidity index (CCI) < 3; regardless of gender; (3) Patients who have received at least one course of systemic therapy (including immunochemotherapy, radiotherapy, autologous hematopoietic stem cell transplantation) without response (complete response or partial response) or relapsed disease (4) Life expectancy of at least 3 months (5) Good organ function: total bilirubin = 1.5×ULN; alanine aminotransferase and aspartate aminotransferase =2×ULN; serum creatinine = 1.5×ULN; or in the presence of lymphoma involving the liver, alanine aminotransferase and aspartate aminotransferase =5× ULN (6) Cardiac ultrasound: left ventricular ejection fraction =45% (7) Lung function: forced expiratory volume in one second (FEV1) =60% and diffusing capacity for carbon monoxide (DLCO) =50% (8) According to the 2014 Lugano criteria, there should be at least one measurable lymphoma lesion
Exclusion criteria
Exclusion criteria: (1) Those who have used polatuzumab vedotin before (2) Have a serious infection which is not controlled (3) Has a history of immunodeficiency, including a positive HIV test, or has other acquired, congenital immunodeficiency disorders (4) Those who have contraindications to any drug in the combination therapy regimen (Pola-G-GDP). (5) Poor compliance (6) Those who are considered unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year overall survival;1-year progression free survival;received ASCT rate;hematologic toxicity;non-hematologic toxicity;complete response;partial remission; | — |
Countries
China
Contacts
Public ContactBai Jiefei
Beijing Hospital
Outcome results
None listed