A Multicenter, Prospective Phase I/II Trial to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome in Combination With Cyclophosphamide, Vincristine, Prednisone, and Rituximab in Patients With Newly Diagnosed DLBCL

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years;

• Histologically confirmed newly diagnosed diffuse large B-cell lymphoma;

• Patients must have been untreated, including chemotherapy, targeted therapy, immunotherapy, radiotherapy;

• There must be at least one measurable lesion per the Lugano2014 criteria;

• For lymph lesion, the long axis must be greater than 1.5cm with 18F-deoxyglucose (18FDG) PET-CT positive;

• Ann Arbor stages II-IV;

• ECOG score 0\

‣ 2;

• Expected survival time ≥3 months;

• a.)Patients should meet the following requirements and must not have received treatment with cell growth factors or blood products within 14 days prior to the hematology test: Absolute value of neutrophils ≥ 1.5 × 10\^9/L; Platelet ≥ 75 × 10\^9/L; Hemoglobin≥80g/L. For patients with bone marrow involvement of lymphoma, the requirements are adjusted as follows: Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L; Platelet count ≥ 50 × 10\^9/L; Hemoglobin level ≥ 75 g/L.

• b.)Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; AST and ALT ≤ 5 × ULN for patients with liver involvement. Total bilirubin ≤1.5 × ULN (≤ 3 × ULN for patients with Gilbert syndrome); c.)Creatinine clearance ≥ 50 mL/min or serum creatinine ≤ 2× ULN; d.)Coagulation function: prothrombin time or activated partial thromboplastin time≤ 1.5 × ULN, and international normalized ratio ≤ 1.5;

⁃ Female patients of childbearing age must have a negative pregnancy test at the time of enrollment within one week. And patients must agree to use an effective method of contraception from the study initiation until at least 12 months after the last treatment;

⁃ Able to understand and comply with the study, and voluntarily sign informed consent; -

Locations
Other Locations
China
Institute of Hematology & Blood Disease Hospital
RECRUITING
Tianjin
Contact Information
Primary
Wei Liu
liuwei@ihcams.ac.cn
+86-022-23608461
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 108
Treatments
Experimental: R-CMOP
R-CMOP regimen includes rituximab (R), cyclophosphamide (C), mitoxantrone hydrochloride liposome injection (M), vincristine (O), and prednisone (P).~The regimen will be administered every 3 weeks, for a maximum of 6 cycles.
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov