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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
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.