Opening soonPhase 2Ages 18 Years to 80 Years
A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1
Sponsor: Institute of Hematology & Blood Diseases Hospital, China · NCT07034508 on ClinicalTrials.gov ↗
Conditions studied
DLBCL - Diffuse Large B Cell Lymphoma
What it tests
- Polatuzumab Vedotindrug
- Rituximabdrug
- Cyclophosphamidedrug
- Doxorubicindrug
- Prednisonedrug
Where it's running1 site
1 international site
China Institute of Hematology and Blood Diseases Hospital
Tianjin, China 300020
- Liang Huang(contact)13971600192[email protected]
See the official eligibility language
Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.
Inclusion Criteria: * Newly diagnosed, untreated, biopsy-proven CD20 positive diffuse large B-cell lymphoma (DLBCL) * Age ≥18yo and ≤80yo at the time of signing consent * International Prognostic Index (IPI) score 0-1 * ECOG 0-2 * Have measurable disease on a pre-chemotherapy PET/CT, defined as at least one bi-dimensionally measurable nodal lesion of \>1.5cm in longest dimension, or at least one bi-dimensionally measurable extranodal lesion of \>1.0cm in longest dimension * Life expectancy greater than or equal to (\>/=)12 months * Left ventricular ejection fraction (LVEF) \>/= 50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) * Adequate hematologic function * Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from donating eggs. * Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm. Exclusion Criteria: * Patients with central nervous system or primary mediastinal lymphoma, and patients with transformed lymphoma. * Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc. * Pregnant or lactating women. * Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV; positive by RNA polymerase chain reaction \[PCR\]) infection. * Patients with concurrent other tumors or a history of tumors, or who have received anti-tumor treatment (including major surgery) within the last 4 weeks. * Allergic reactions to polatuzumab vedotin. * Other conditions where the investigator deems the patient ineligible for this study.
Updated 2025-06-24 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.