Diffuse Large B-Cell Lymphoma
Conditions
Keywords
DLBCL, R-CHOP, Liposomal Mitoxantrone
Brief summary
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).
Interventions
DRUGR-CMOP Regimen
Rituximab intravenous drip, Cyclophosphamide intravenous drip, Liposomal Mitoxantrone intravenous drip, Vincristine intravenous drip, Prednisone orally
DRUGR-CHOP Regimen
Rituximab intravenous drip, Cyclophosphamide intravenous drip, Doxorubicinin intravenous drip, Vincristine intravenous drip, Prednisone orally
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Aged ≥18,≤80 years, both male and female. 2. Pathologically confirmed DLBCL 3. No prior treatment for 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- 6. Expected survival ≥3 months. 7. International Prognostic Index (IPI) ≤ 2 8. Sufficient bone marrow, liver, and kidney function. Key
Exclusion criteria
1. Other types of LBCL:Primary Cutaneous Diffuse Large B-cell Lymphoma (Leg Type), Primary Mediastinal (Thymic) Large B-cell Lymphoma, Lymphomatoid Granulomatosis, ALK-positive Diffuse Large B-cell Lymphoma, Plasmablastic Lymphoma, Intravascular Large B-cell Lymphoma, T-cell/Histiocyte-rich Large B-cell Lymphoma, and others. 2. Transformed DLBCL. 3. Patients with central nervous system involvement, or those who require high-dose methotrexate for prevention. 4. The patients had previously received antitumor therapy. 5. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome. 6. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception. 7. Mentally ill persons or persons unable to obtain informed consent. 8. 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 assessed by the independent review committee | 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. | To investigate the antitumor efficacy |
| RP2D(Phase Ib) | Cycle 1 in R-CMOP group (28 days) | Phase II Recommended Dose |
| DLT(Phase Ib) | Cycle 1 in R-CMOP group (28 days) | Dose-limiting toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Overall survival(OS) | Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment | To investigate the antitumor efficacy |
| 2-year event-free survival (EFS) rate assessed by the investigators | 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. | To investigate the anti-tumor efficacy |
| Complete response rate (CRR) | Up to 24 weeks | To investigate the antitumor efficacy |
| Objective response rate (ORR) | Up to 24 weeks | To investigate the antitumor efficacy |
| AE and SAE (Phase Ib) | Up to 24 weeks | Number of participants with adverse events (AE) and severe adverse events (SAE) in phase Ib |
| 2-year Progression-free survival(PFS) | Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment | To investigate the antitumor efficacy |
Countries
China
Contacts
Primary ContactQingqing Cai, MD. PhD.
Outcome results
None listed