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Orelabrutinib combined with rituximab for the treatment of elderly patients with newly diagnosed non-GCB diffuse large B-Cell lymphoma under the guidance of genetic subtype: A prospective , multicenter, single-arm, response-adaptive clinical study (Origin)

Orelabrutinib combined with rituximab for the treatment of elderly patients with newly diagnosed non-GCB diffuse large B-Cell lymphoma under the guidance of genetic subtype: A prospective , multicenter, single-arm, response-adaptive clinical study (Origin)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077256
Enrollment
Unknown
Registered
2023-11-02
Start date
2023-11-06
Completion date
Unknown
Last updated
2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse large B-cell Lymphoma

Interventions

Research group:Study combined miniCHOP after induction of OR Orelabrutinib 150mg QD d1-21, Ruximab 375mg / m2 d1)

Sponsors

The First Affiliated Hospital of Zhejiang University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1.Initial-treatment DLBCL was confirmed based on histopathology, and the immunohistochemical examination was positive for CD20. 2.Human subtype by pathological immunohistochemistry. 3.At least one radiologically measurable lesion was present. 4.Age was 65 years old at the time of enrollment. 5.Informed consent was obtained from the patient or family members.

Exclusion criteria

Exclusion criteria: 1.Pregnancy, lactating women, and patients of childbearing age who are reluctant to use contraception. 2.Abnormal liver function (1.5 times total bilirubin> the upper limit of normal, ALT / AST> 2.5 times normal ALT / AST> 5 times normal ALT / AST), abnormal renal function (1.5 times the upper limit of serum creatinine> normal). 3.Neutrophil absolute count 1x103 copies / ml), untreated syphilis positive, and patients with active TB. 9.Previous history of lymphoma, considered in a patient with Richter's syndrome. 10.Other investigator judged ineligible for this study.

Design outcomes

Primary

MeasureTime frame
complete remission rate (CRR) ;

Secondary

MeasureTime frame
progression-free survival(PFS);Event-free survival(EFS);Overall response rate(ORR);

Countries

China

Contacts

Public ContactWazhou Xie

The First Affiliated Hospital of Zhejiang University Medical College

xiewanz@163.com+86 13 957 166 1281

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026