NCT05348213 Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma
| NCT ID | NCT05348213 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2022-05-16 |
| Primary Completion | 2025-06-01 |
Trial Parameters
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Brief Summary
A single-center, open, single-arm clinical study of the efficacy and safety of a novel targeted agent in combination with R-ICE in the treatment of relapsed and refractory diffuse Large B-cell lymphoma.
Eligibility Criteria
Inclusion Criteria: * DLBCL was confirmed by histology according to world Health Organization (WHO) disease classification (excluding primary central lymphoma and HIV-associated lymphoma); * There are evaluable lesions detected by PET/CT; * Life expectancy of more than 3 months; * Prior treatment with sufficient first-line anti-lymphoma therapy, no remission within 90 days of the last administration, or disease progression after sufficient first-line anti-lymphoma therapy, and no current anti-lymphoma therapy (≥2 weeks since the last anti-lymphoma therapy). Patients were allowed to receive hormone drugs or rituximab at least 1 week after enrollment for symptom control reasons; * 18≤ age ≤75 years old, male and female; * ECOG 0-2 points; * No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) : ① Absolute value of neutrophil count ≥1500/mm3; Platelet count ≥75,000/mm3 ② Total