Relapsed/Refractory HIV-associated Diffuse B-Cell Lymphoma
Conditions
Interventions
Glofit-DHAP/X treatment group:Glofitamab in combination with dexamethasone, high-dose cytarabine, and cisplatin or oxaliplatin
Sponsors
Chongqing University Cancer Hospital,China
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form. 2. Aged 18 years or older. 3. Life expectancy >=12 weeks. 4. HIV-positive with a CD4 count >=150 cells/µL. 5. Undetectable HIV RNA. 6. Histologically confirmed diffuse large B-cell lymphoma (DLBCL). 7. Received at least one prior line of systemic therapy, including an anti-CD20 monoclonal antibody (e.g., rituximab) and an anthracycline-based regimen. 8. Disease relapse or refractory status after first-line chemoimmunotherapy. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. 10. Candidate for high-dose chemotherapy followed by autologous stem cell transplantation (ASCT). 11. On a concurrent antiretroviral therapy (ART) regimen per current International AIDS Society (IAS) guidelines during chemotherapy. 12. Adequate organ function (hematologic, hepatic, and renal), defined as:Hemoglobin >=9.0 g/dL (>=90 g/L);Absolute neutrophil count (ANC) >=1.0 × 10?/L (>=1000/µL);Platelet count >=75 × 10?/L (>=75,000/µL) without transfusion within 1 week prior to study treatment initiation.
Exclusion criteria
Exclusion criteria: 1.Prior treatment with glofitamab or any other bispecific antibody targeting CD20 and CD3. 2.Prior therapy with cytarabine or oxaliplatin/cisplatin. 3.Grade >1 peripheral neuropathy (per NCI CTCAE v5.0) at enrollment. 4.Radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anticancer agents within 2 weeks before the first study treatment. 5.Monoclonal antibody therapy for cancer within 4 weeks before the first study treatment. 6.Primary mediastinal B-cell lymphoma (PMBCL). 7.Primary or secondary CNS lymphoma at enrollment or a history of CNS lymphoma. 8.Current or prior CNS disorders, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative diseases. 9.Known or suspected history of hemophagocytic lymphohistiocytosis (HLH). 10.Known history of progressive multifocal leukoencephalopathy (PML). 11.Persistent toxicities from prior anticancer therapy not resolved to Grade 30 mg/day prednisone or equivalent). 19.Participants on <=30 mg/day prednisone (or equivalent) must be on a stable dose for =4 weeks before Cycle 1 Day 1.Short-term (<=7 days) systemic steroids (<=100 mg prednisone equivalent/day) for lymphoma-related symptom control prior to study treatment are permitted.Major surgery (excluding diagnostic procedures) within 4 weeks before the first study treatment. 20.Clinically significant history of liver cirrhosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response Rate (CRR);Mobilization-Adjusted Response Rate (MARR);Progression-Free Survival (PFS);Overall survival (OS);Adverse events (AEs); | — |
Countries
China
Contacts
Public ContactYao Liu
Chongqing University Cancer Hospital
Outcome results
None listed