OncoMatch/Clinical Trials/NCT06977711
Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)
Is NCT06977711 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for diffuse large b-cell lymphoma.
Treatment: Loncastuximab · Roflumilast · Rituximab · Cyclophosphamide · Vincristine · Doxorubicin · Prednisone — This study is developed by the investigator and is a, phase I, single arm, clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome. The types of treatments given will be shared with participants. The aims are: 1. To assess the safety and how well the participants tolerate the treatment 2. Assess the response of the tumor to treatment to estimate complete response 3. Assess the response of the tumor to treatment to estimate progression-free survival
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: BCL2 rearrangement
Allowed: MYC rearrangement
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
No prior systemic therapy for lymphoma
Cannot have received: allogeneic bone marrow transplant
Exception: allowed if >12 months before screening
Prior allogeneic bone marrow transplant within 12 months of screening date
Cannot have received: autologous stem cell transplant
Exception: allowed if >6 months before screening
Prior autologous stem cell transplant within 6 months of screening date
Cannot have received: immunotherapy
Exception: allowed if >6 months before drug dosing
Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months prior to drug dosing
Cannot have received: chemotherapy
Exception: allowed if >6 months before drug dosing
Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months prior to drug dosing
Cannot have received: radiation therapy
Exception: allowed if >6 months before drug dosing
Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months prior to drug dosing
Cannot have received: investigational therapy
Exception: allowed if >6 months before drug dosing
Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months prior to drug dosing
Lab requirements
Blood counts
Platelet count ≥ 50,000/µL, with or without transfusion support; ANC ≥ 1000/µL, with or without chronic granulocyte growth factor support; Hemoglobin ≥8 g/dL, with or without transfusion support
Kidney function
Creatinine clearance ≥30 ml/min by Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 × ULN (unless indirect bilirubin is elevated due to Gilbert's syndrome or hemolysis); AST and ALT ≤ 3 × ULN
Cardiac function
Left ventricular ejection fraction of at least 45% by either echocardiography or radionucleotide angiography
Creatinine clearance ≥30 ml/min by Cockcroft-Gault formula; Total bilirubin ≤ 1.5 × ULN (unless indirect bilirubin is elevated due to Gilbert's syndrome or hemolysis); AST and ALT ≤ 3 × ULN; Platelet count ≥ 50,000/µL, with or without transfusion support; ANC ≥ 1000/µL, with or without chronic granulocyte growth factor support; Hemoglobin ≥8 g/dL, with or without transfusion support. Left ventricular ejection fraction of at least 45% by either echocardiography or radionucleotide angiography.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University Hospital System · San Antonio, Texas
- University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center · San Antonio, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify