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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
Guangzhou, China, China
RECRUITINGGansu Cancer Hospital
Lanzhou, Gansu, China
RECRUITING2-year event-free survival (EFS) rate
To investigate the preliminary anti-tumor efficacy
Time frame: Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment
Complete response rate (CRR)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 8 cycles (each cycle is 21 days)
Disease-free survival (DFS)
To investigate the preliminary anti-tumor efficacy
Time frame: 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
Objective response rate (ORR)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 8 cycles (each cycle is 21 days)
Progression-free survival (PFS)
To investigate the preliminary anti-tumor efficacy
Time frame: 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
Overall survival (OS)
To investigate the preliminary anti-tumor efficacy
Time frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
To identify the incidence of AE and SAE
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Dongguan People's Hospital
Dongguan, Guangdong, China
RECRUITINGFifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGFirst People's Hospital of Guangzhou
Guangzhou, Guangdong, China
RECRUITINGGuangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGSecond Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGFirst Affiliated Hospital of Shantou University Medical College.
Shantou, Guangdong, China
RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
RECRUITINGZhaoqing First People's Hospital
Zhaoqing, Guangdong, China
RECRUITING...and 1 more locations
Time frame: Through study completion, an average of 2 years