OncoMatch/Clinical Trials/NCT07199296
Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
Is NCT07199296 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Excluded: TP53 abnormality
Disease stage
Required: Stage II, III, IV
Demographics
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.
Frequently asked questions
Is NCT07199296 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with TP53 alterations eligible?
No. TP53 abnormality is an exclusion criterion.
What disease stage is eligible?
Stage II or III or IV is required.
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 qualifyRelated pages