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

• Sponsor: The First Affiliated Hospital of Soochow University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05498259
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29.2
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-Cell Lymphoma	Drug: Orelabrutinib; Biological: Rituximab; Drug: CHOP-like Regimen	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
• Actual Study Start Date: Jul 27, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orelabrutinib+R-CHOP-like Orelabrutinib plus Rituximab for 21 days; Following Imaging examinations, patients with ≥25% tumor reduction, treat with orelabrutinib 150mg qd orally plus R-CHOP-like for 6 cycles; whereas, patients with <25% tumor reduction, treat with R-CHOP-like alone for 6 cycle	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）, vinca alkaloids（vincristine, vindesine），and glucocorticoid （dexamethasone，prednison）.

Outcome Measures

Primary Outcome Measures

1. Mini response rate [the first 21 days]

   The rate of patients who achieve ≥25% tumor reduction

2. Complete Response Rate [At the end of Cycle 3 and Cycle 6（each cycle is 21 days）]

   The rate of patients who achieved complete response after treatment by OR-CHOP-like

Secondary Outcome Measures

1. Overall Response Rate (ORR) [At the end of Cycle 3 and Cycle 6（each cycle is 21 days）]

   The rate of patients who achieved CR or PR after treatment by OR-CHOP-like

2. Progression-free survival（PFS） [up to 18 month after the last patient's enrollment]

   PFS will be assessed from the first OR(Orelabrutinib plus Rituximab) given to date of progression, relapse, death or end of follow-up

3. Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events [initiation of study drug until 30 days after last dose]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Histologically confirmed Non-GCB DLBCL

2. Age ≥18 and ≤75 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006

Sponsors and Collaborators

• The First Affiliated Hospital of Soochow University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital of Soochow University
• ClinicalTrials.gov Identifier: NCT05498259
• Other Study ID Numbers: Jinzm 002
• First Posted: Aug 12, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The First Affiliated Hospital of Soochow University: Orelabrutinib
• Additional relevant MeSH terms: Lymphoma, Large B-Cell, Diffuse; Rituximab

Study Results

No Results Posted as of Aug 12, 2022