RecruitingPhase 2NCT06699472

A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib

A Prospective, Randomized, Controlled Clinical Study on the Prevention of VDC/IE Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib

Sponsor

Fudan University

Enrollment

22 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

Ewing Sarcoma Myelosuppression

Summary

This study is a prospective, open label, randomized controlled clinical trial aimed at patients with Ewing's sarcoma who have not received systematic anti-tumor treatment in the past. The aim is to evaluate the efficacy and safety of prophylactic use of Trilaciclib before VDC+IE chemotherapy. Patients with Ewing's sarcoma who have not received systemic anti-tumor therapy in the past will be screened for qualified subjects who meet the inclusion criteria after signing informed consent. Eligible patients will be randomly divided into an experimental group and a control group in a 1:1 ratio. The control group will receive alternating VDC+IE chemotherapy for 3 weeks, a total of 17 cycles, or until disease progression, intolerable adverse reactions, or withdrawal of informed consent occur. The experimental group received VDC+IE alternating chemotherapy combined with Trilaciclib, with 3 weeks as one course of treatment, for a total of 17 cycles or until disease progression, intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other situations specified in the protocol where treatment should be discontinued. Both the control group and the experimental group can receive supportive nursing treatment according to clinical needs.

Eligibility

Min Age: 14 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called trilaciclib, given before chemotherapy, can prevent dangerously low blood cell counts (myelosuppression) — a common and serious side effect — in young patients with Ewing's sarcoma (a bone and soft tissue cancer). **You may be eligible if...** - You are between 14 and 40 years old - You have been confirmed by biopsy to have Ewing's sarcoma - You have not received any cancer treatment other than surgery in the past - You have a good performance level and adequate organ and bone marrow function **You may NOT be eligible if...** - You have already received chemotherapy, immunotherapy, or radiation for this cancer - You are under 14 or over 40 years old - You have poor organ function or bone marrow problems - Your expected survival is less than 3 months Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChemotherapy

Vincristine (V), intravenous injection, 1.5 mg/m2 (maximum not exceeding 2mg), D1, odd cycle administration Doxorubicin (D), intravenous infusion, 75mg/m2, D1, odd cycle administration When the cumulative dose of doxorubicin is ≥ 375mg/m2, replace it with actinomycin D 1.25mg/m2 Cyclophosphamide (C), intravenous infusion, 1200mg/m2, D1, odd cycle administration Ifosfamide (I), intravenous infusion, 1800mg/m2, D1-5, even cycle administration Etoposide (E), intravenous infusion, 100mg/m2, D1-5, even cycle administration

DRUGTrilaciclib Injection [Cosela]

Trilaciclib, intravenous infusion, 240 mg/m2, administered following chemotherapy (2 hours after completion of vincristine administration and within 4 hours before administration of other chemotherapy drugs)