Phase Ib Clinical Trial of Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Treatment Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)
The University of Texas Health Science Center at San Antonio
Summary
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
Description
Exploratory analyses include cell free DNA (cfDNA). Each subject's disease will be biologically characterized at baseline. Enrolled subjects will receive 2 cycles of chemotherapy free therapy composed of loncastuximab 0.15 mg/kg, rituximab 375 mg/m2, and roflumilast 500 ug po daily; followed by 6 cycles of chemoimmunotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) at standard of care (SOC) doses, in combination with loncastuximab and roflumilast 500 ug po daily. Loncastuximab at a dose of 0.075 mg/kg will be added to other chemoimmunotherapy agents…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men and women 18 years of age or older. 2. Pathologically proven diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS). \- Patients with Diffuse large B-cell lymphoma/ high grade B-cell lymphoma with MYC (myelocytomatosis oncogene) and BCL2 (B-cell lymphoma 2) rearrangements are allowed. 3. No prior systemic therapy for lymphoma. 4. Subject has provided informed consent. 5. Subject is willing and able to comply with clinic visits and procedure outlined in the study protocol. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. Lif…
Interventions
- DrugLoncastuximab
Intravenous (IV) administration 0.15 mg/kg day 1 cycles 1-2, and 0.075mg/kg day 1, cycles 3-5
- DrugRoflumilast
Oral administration of 500mcg days 1-21, cycles 1-8
- DrugRituximab
IV administration of 375mg/m2 day 1, cycles 1-8
- DrugCyclophosphamide
IV administration of 750mg/m2 day 1, cycles 3-8
- DrugVincristine
IV administration 1.4mg/m2 (max 2mg) day 1, cycles 3-8
- DrugDoxorubicin
IV administration 50mg/m2 day 1, cycles 3-8
- DrugPrednisone
Locations (2)
- University Hospital SystemSan Antonio, Texas
- University of Texas Health Science Center San Antonio at the Cancer Therapy and Research CenterSan Antonio, Texas