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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

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