RecruitingPhase 1Phase 2NCT06594640

R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

108 participants

Start Date

May 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new chemotherapy combination called R-CMOP for people newly diagnosed with diffuse large B-cell lymphoma (DLBCL), an aggressive type of blood cancer. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with diffuse large B-cell lymphoma, confirmed by biopsy - You have not yet received any chemotherapy, targeted therapy, immunotherapy, or radiation - You have at least one measurable tumor that can be tracked on imaging - Your cancer is at stage II, III, or IV - Your general health score (ECOG) is 0-2 and expected survival is at least 3 months - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have already received any treatment for this lymphoma - Your blood counts, liver enzymes, or kidney function are below required levels - You are pregnant (negative pregnancy test required if applicable) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMitoxantrone Hydrochloride Liposome

assigned dose according to the 3+3 dose-escalation design in part 1, RP2D in part 2, D2

DRUGRituximab (R)

375mg/m2, D2

DRUGCyclophosphamide (CTX)

750mg/m2, D2

DRUGVincristin

1.2mg/m2, maximum 2mg, D2

DRUGPrednisolone

60mg/m2, D2-6


Locations(1)

Institute of Hematology & Blood Disease Hospital

Tianjin, Tianjin Municipality, China

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NCT06594640


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