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Trial Title:
Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
NCT ID:
NCT05498259
Condition:
Diffuse Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Rituximab
Conditions: Keywords:
Orelabrutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib
Description:
Orelabrutinib 150mg qd PO
Arm group label:
Orelabrutinib+R-CHOP-like
Intervention type:
Biological
Intervention name:
Rituximab
Description:
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle
Arm group label:
Orelabrutinib+R-CHOP-like
Intervention type:
Drug
Intervention name:
CHOP-like Regimen
Description:
cyclophosphamide, anthracene nucleus chemotherapeutics(doxorubicin,liposomal doxorubicin,
etc.), vinca alkaloids(vincristine, vindesine, etc.),and glucocorticoid
(dexamethasone,prednison, etc.).
Arm group label:
Orelabrutinib+R-CHOP-like
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengming Jin
Start date:
July 27, 2022
Completion date:
January 1, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05498259