OncoMatch/Clinical Trials/NCT05800366
A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma
Is NCT05800366 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for lymphoma.
Treatment: Glofitamab · Polatuzumab · Rituximab · Doxorubicin Hydrochloride · Cyclophosphamide · Prednisone — The goal of this research study is to evaluate the combination of study drugs, Glofitamab and Polatuzumab, and a standard chemotherapy regimen, R-CHP, as a treatment for high-risk diffuse large B-cell lymphoma. The names of the treatment interventions involved in this study are: * Glofitamab (T-cell bispecific antibody) * Polatuzumab (antibody-drug conjugate) * R-CHP (a chemotherapy regimen comprised of Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, and Prednisone)
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 overexpression
Previously untreated patients with CD20-positive DLBCL
Allowed: MYC translocation
HGBCL with translocations of MYC and BCL-2, or MYC and BCL-6
Allowed: BCL2 translocation
HGBCL with translocations of MYC and BCL-2
Allowed: BCL6 translocation
HGBCL with translocations of MYC and BCL-6
Allowed: ALK fusion
ALK-positive large B-cell lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anthracycline
prior receipt of anthracyclines
Cannot have received: cytotoxic chemotherapy
Exception: palliative, short-term treatment with corticosteroids (up to 7 days); one cycle of R-CHOP
Prior therapy for DLBCL with the exception of: Palliative, short-term treatment with corticosteroids (up to 7 days). One cycle of R-CHOP
Cannot have received: radiation therapy
Prior radiotherapy to the mediastinal/pericardial region
Cannot have received: cytotoxic chemotherapy
Prior treatment with cytotoxic drugs within 5 years of screening for any condition (e.g., cancer, rheumatoid arthritis)
Cannot have received: anti-CD20 antibody
prior use of any anti-CD20 antibody
Cannot have received: monoclonal antibody
Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
Cannot have received: investigational therapy
any investigational therapy within 28 days prior to the start of Cycle 1
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL without transfusion for 14 days before first treatment; ANC ≥ 1,000/μL; Platelet count ≥ 75,000/μL
Kidney function
serum creatinine ≤1.5 x ULN or creatinine clearance (by Cockcroft-Gault) ≥ 40 ml/min
Liver function
Total bilirubin ≤ 1.5 x institutional ULN or < 3 x ULN in participants with Gilbert's disease; AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN; PT or INR > 1.5 the ULN in the absence of therapeutic anticoagulation or lupus anticoagulant
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac MUGA scan or ECHO
Adequate hematologic function... Adequate organ as defined below... Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami Sylvester Cancer Center · Miami, Florida
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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