A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

Sponsor

Shandong Tumor Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05933967

Collaborator

The First Affiliated Hospital of Nanchang University (Other)

Enrollment

Locations

Arm

Anticipated Duration (Months)

15.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.

Condition or Disease	Intervention/Treatment	Phase
The First Affiliated Hospital of Nanchang University	Drug: Orelabrutinib+R-CHOP	Phase 2

Detailed Description

The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy

Study Design

Study Type:

Interventional

Anticipated Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: orelabrutinib+R-CHOP	Drug: Orelabrutinib+R-CHOP Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.

Arm

Intervention/Treatment

Experimental: orelabrutinib+R-CHOP

Drug: Orelabrutinib+R-CHOP

Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.

Outcome Measures

Primary Outcome Measures

complete response rate [up to 24 weeks]

Secondary Outcome Measures

ORR [up to 24 weeks]
ORR is defined as the proportion of patients with a best response of CR or PR
2 years progression-free survival [From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]]
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
2 years overall survival [From date of receiving the first dose until the date of death from any cause,assessed up to 2 years]
2 years overall survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive
The occurrence of adverse events and serious adverse events [up to 30 months]
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma
Age 18-70 years
ECOG performance status 0-2
Ann Arbor stage II-IV
8.Subjects who in line with the testing standard of the clinical trial laboratory
Life expectancy ≥ 3months

Exclusion Criteria:

• systemic lymphoma involved CNS.
Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases.
uncontrolled infections (including HBV, HCV, HIV/AIDS)
Subjects who prepared for transplantation
Pregnancy or active lactation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Ailliated Hospital of Nanchang University	Nanchang	Jiangxi	China
2	Shandong Tumor Hospital	Jinan	Shandong	China

Sponsors and Collaborators

Shandong Tumor Hospital
The First Affiliated Hospital of Nanchang University

Investigators

Study Chair: zengjun Li, Shandong Tumor Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zengjun Li, Head of the Hematology Department, Shandong Tumor Hospital

ClinicalTrials.gov Identifier:

NCT05933967

Other Study ID Numbers:

SDTH-NHL-001

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 6, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma, Large B-Cell, Diffuse

Study Results

No Results Posted as of Jul 6, 2023