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

Primary Purpose

Diffuse Large B-Cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Orelabrutinib
Rituximab
CHOP-like Regimen
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring Orelabrutinib

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orelabrutinib+R-CHOP-like

Arm Description

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, withdraw from the study，treat with R-CHOP-like alone for 6 cycle

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Response Rate (ORR)
The rate of patients who achieved CR or PR after treatment by OR-CHOP-like
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
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
Mini response rate
The rate of patients who achieve ≥25% tumor reduction after OR treatment

Full Information

First Posted
August 8, 2022
Last Updated
February 1, 2023
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05498259
Brief Title
Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
Official Title
A Phase 2 Study of Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma
Keywords
Orelabrutinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orelabrutinib+R-CHOP-like
Arm Type
Experimental
Arm Description
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, withdraw from the study，treat with R-CHOP-like alone for 6 cycle
Intervention Type
Drug
Intervention Name(s)
Orelabrutinib
Intervention Description
Orelabrutinib 150mg qd PO
Intervention Type
Biological
Intervention Name(s)
Rituximab
Intervention Description
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
CHOP-like Regimen
Intervention Description
cyclophosphamide, anthracene nucleus chemotherapeutics（doxorubicin，liposomal doxorubicin, etc.）, vinca alkaloids（vincristine, vindesine, etc.），and glucocorticoid （dexamethasone，prednison, etc.）.
Primary Outcome Measure Information:
Title
Complete Response Rate
Description
The rate of patients who achieved complete response after treatment by OR-CHOP-like
Time Frame
At the end of Cycle 6（each cycle is 21 days）
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
The rate of patients who achieved CR or PR after treatment by OR-CHOP-like
Time Frame
At the end of Cycle 3 and Cycle 6（each cycle is 21 days）
Title
Progression-free survival（PFS）
Description
PFS will be assessed from the first OR(Orelabrutinib plus Rituximab) given to date of progression, relapse, death or end of follow-up
Time Frame
up to 24 month after the end of last patient's treatment
Title
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
Description
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
Time Frame
initiation of study drug until 30 days after last dose
Title
Mini response rate
Description
The rate of patients who achieve ≥25% tumor reduction after OR treatment
Time Frame
the first 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed Non-GCB DLBCL Age ≥18 and ≤70 years At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm) ECOG performance status 0-2 Lymphoma International Prognostic Score (IPI) ≥ 2 Life expectancy ≥ 6 months Adequate organ and marrow function Agreement to practice birth control from the time of enrollment until the follow-up period of the study Exclusion Criteria: Received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis All patients with primary central nervous system lymphoma History of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist Requires treatment with strong /moderate CYP3A inhibitors or inducers 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 HIV infection and/or active hepatitis B or active hepatitis C infection Uncontrolled active systemic infection Known hypersensitivity or contraindications to any drug involved in the study Pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhengming Jin
Phone
+86 0512 67781856
Email
jinzhengming519519@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Changju Qu
Phone
+86 0512 67781856
Email
qcj310@163.com
Facility Information:
Facility Name
the First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengming Jin

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All the data would be available at the First Affiliated Hospital and other researchers after the end of the study
IPD Sharing Time Frame
after the end of the study

Learn more about this trial

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

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