Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title:

A Phase 2 Study of Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498259
• Other study ID #: ORIENT
• Status: Recruiting
• Phase: Phase 2
• Start date: July 27, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: August 2022
• Source: The First Affiliated Hospital of Soochow University
• Contact: Zhengming Jin
• Phone: +86 0512 67781856
• Email: jinzhengming519519[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients

Description:

The study will start with an initial 21-days of induction therapy with orelabrutinib and rituximab，following imaging examinations to evaluate response rates. Then treatment with 6 cycles chemoimmunotherapy (R-CHOP-like) either alone or in combination with orelabrutinib will depend on response during induction phase. Each cycle is 21 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed Non-GCB DLBCL

2. Age =18 and =70 years

3. At least one measurable lesion,measurable lymph nodes or masses of at least 15 millimeter (mm)

4. ECOG performance status 0-2

5. Lymphoma International Prognostic Score (IPI) = 2

6. Life expectancy = 6 months

7. Adequate organ and marrow function

8. Agreement to practice birth control from the time of enrollment until the follow-up period of the study

Exclusion Criteria:

1. Received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis

2. All patients with primary central nervous system lymphoma

3. History of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist

4. Requires treatment with strong /moderate CYP3A inhibitors or inducers

5. Uncontrolled comorbidity or complications, including but not limited to: symptomatic congestive heart failure (New York Heart Association Class III-IV) or symptomatic or poorly controlled arrhythmias and/or significant pulmonary disease

6. HIV infection and/or active hepatitis B or active hepatitis C infection

7. Uncontrolled active systemic infection

8. Known hypersensitivity or contraindications to any drug involved in the study

9. Pregnant or lactating women

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Orelabrutinib
Orelabrutinib 150mg qd PO

Biological:
• Rituximab
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle

Drug:
• CHOP-like Regimen
cyclophosphamide, anthracene nucleus chemotherapeutics(doxorubicin,liposomal doxorubicin, etc.), vinca alkaloids(vincristine, vindesine, etc.),and glucocorticoid (dexamethasone,prednison, etc.).

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate	The rate of patients who achieved complete response after treatment by OR-CHOP-like	At the end of Cycle 6(each cycle is 21 days)
Secondary	Overall Response Rate (ORR)	The rate of patients who achieved CR or PR after treatment by OR-CHOP-like	At the end of Cycle 3 and Cycle 6(each cycle is 21 days)
Secondary	Progression-free survival(PFS)	PFS will be assessed from the first OR(Orelabrutinib plus Rituximab) given to date of progression, relapse, death or end of follow-up	up to 24 month after the end of last patient's treatment
Secondary	Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events	The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events	initiation of study drug until 30 days after last dose
Secondary	Mini response rate	The rate of patients who achieve =25% tumor reduction after OR treatment	the first 21 days