This is a prospective, randomized, controlled, multicenter, phase II clinical trial to evaluate the efficacy and safety of R-CMOP versus R-CHOP in the initial treatment of low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Rituximab intravenous drip, Cyclophosphamide intravenous drip, Liposomal Mitoxantrone intravenous drip, Vincristine intravenous drip, Prednisone orally
Rituximab intravenous drip, Cyclophosphamide intravenous drip, Doxorubicinin intravenous drip, Vincristine intravenous drip, Prednisone orally
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGGansu Provincial Cancer Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGThe Fifth Affiliated Hospital of Guangzhou Medical University.
2-year event-free survival (EFS) rate assessed by the independent review committee
To investigate the antitumor efficacy
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the independent review committee's assessment.
RP2D(Phase Ib)
Phase II Recommended Dose
Time frame: Cycle 1 in R-CMOP group (28 days)
DLT(Phase Ib)
Dose-limiting toxicity
Time frame: Cycle 1 in R-CMOP group (28 days)
2-year event-free survival (EFS) rate assessed by the investigators
To investigate the anti-tumor efficacy
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the investigators' assessment.
AE and SAE (Phase Ib)
Number of participants with adverse events (AE) and severe adverse events (SAE) in phase Ib
Time frame: Up to 24 weeks
2-year Progression-free survival(PFS)
To investigate the antitumor efficacy
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
2-year Overall survival(OS)
To investigate the antitumor efficacy
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
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Guangzhou, Guangdong, China
The Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGThe Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
RECRUITINGGuangxi Zhuang Autonomous Region Cancer Hospital
Guilin, Guangxi, China
NOT_YET_RECRUITINGGanzhou Cancer Hospital
Ganzhou, Jiangxi, China
NOT_YET_RECRUITINGJiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGBeijing Tongren Hospital
Beijing, China
NOT_YET_RECRUITINGObjective response rate (ORR)
To investigate the antitumor efficacy
Time frame: Up to 24 weeks
Complete response rate (CRR)
To investigate the antitumor efficacy
Time frame: Up to 24 weeks