OncoMatch/Clinical Trials/NCT07199296
Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
Is NCT07199296 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Orelabrutinib and Rituximab (R) for mantle cell lymphoma (mcl).
Treatment: Orelabrutinib · Rituximab (R) · BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) · orelabrutinib maintenance — This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib in combination with rituximab with optional autologous hematopoietic stem cell transplantation in patients with non-high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Excluded: TP53 abnormality
Disease stage
Required: Stage II, III, IV
Prior therapy
Cannot have received: btk inhibitor
Lab requirements
Blood counts
white blood cell count ≥3.0×10^9/l, absolute neutrophil count ≥1.5×10^9/l, hemoglobin ≥90g/l, platelet count ≥75×10^9/l
Kidney function
serum creatinine 44-133 mmol/l
Liver function
transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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