Diffuse Large B Cell Lymphoma (DLBCL)
Conditions
Keywords
DLBCL, Orelabrutinib, CD5-positive, R-CHOP
Brief summary
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.
Detailed description
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients. The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP (orelabrutinib added from the second cycle), followed by 2 cycles of rituximab + orelabrutinib, for a total of 8 treatment cycles. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted. The primary endpoint is the 2-year event-free survival (EFS) rate.
Interventions
DRUGOrelabrutinib Oral Tablet
Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen
DRUGR-CHOP Protocol
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Gansu Cancer Hospital
First Affiliated Hospital of Shantou University Medical College
Southern Medical University, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Second Affiliated Hospital of Guangzhou Medical University
Fifth Affiliated Hospital of Guangzhou Medical University
Shenzhen People's Hospital
Guangzhou First People's Hospital
Dongguan People's Hospital
The First People's Hospital of Zhaoqing
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Subjects fully understand and voluntarily participate in this study and sign informed consent. 2. Aged ≥18 years, both male and female. 3. Pathologically confirmed CD5-positive DLBCL 4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma. 5. Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2. 6. Expected survival ≥3 months. 7. Sufficient bone marrow, liver, and kidney function. Key
Exclusion criteria
1. DLBCL combined with other types of lymphoma. Transformed DLBCL. 2. DLBCL with central nervous system invasion. 3. The patients had previously received BTK inhibitors. 4. The patients have contraindications to any drug in the combined treatment. 5. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome. 6. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug. 7. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception. 8. Mentally ill persons or persons unable to obtain informed consent. 9. The investigators think that the patient is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year event-free survival (EFS) rate | Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment | To investigate the preliminary anti-tumor efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate (CRR) | Up to 8 cycles (each cycle is 21 days) | To investigate the preliminary anti-tumor efficacy |
| Disease-free survival (DFS) | From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | To investigate the preliminary anti-tumor efficacy |
| Objective response rate (ORR) | Up to 8 cycles (each cycle is 21 days) | To investigate the preliminary anti-tumor efficacy |
| Overall survival (OS) | From the date of enrollment until the date of death from ant cause, assessed up to 24 months | To investigate the preliminary anti-tumor efficacy |
| Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0 | Through study completion, an average of 2 years | To identify the incidence of AE and SAE |
| Progression-free survival (PFS) | From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | To investigate the preliminary anti-tumor efficacy |
Other
| Measure | Time frame | Description |
|---|---|---|
| The correlation of gene mutations and alterations in relevant signaling pathways with the efficacy and survival in CD5-positive DLBCL | Through study completion, an average of 2 years | To explore the correlations between gene mutations and response and prognosis |
Countries
China
Contacts
Primary ContactQingqing Cai, MD. PhD.
Backup ContactYi Xia, MD. PhD.
Outcome results
None listed