Preventing chemotherapy-related side effects in Ewing's sarcoma patients 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

This study is testing if adding Trilaciclib to standard chemotherapy can help prevent low blood cell counts in patients with Ewing's sarcoma who haven't had treatment before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 14 Years to 40 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06699472 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Trilaciclib in preventing myelosuppression in patients with Ewing's sarcoma who have not previously undergone systemic anti-tumor treatment. Participants will be randomly assigned to receive either standard chemotherapy or chemotherapy combined with Trilaciclib. The study aims to assess the impact of Trilaciclib on blood cell counts during chemotherapy cycles. The trial will include a total of 17 cycles of treatment, monitoring for disease progression and adverse reactions.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 14 to 40 with histologically confirmed Ewing's sarcoma who have not received prior systemic anti-tumor therapy.

Not a fit: Patients who have previously undergone systemic anti-tumor treatment or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce chemotherapy-related myelosuppression, improving treatment tolerability and outcomes for patients with Ewing's sarcoma.

How similar studies have performed: While the use of Trilaciclib is a novel approach in this specific context, similar studies have shown promise in using CDK4/6 inhibitors to mitigate chemotherapy side effects.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 14 years old and ≤ 40 years old;
* Histologically confirmed Ewing's sarcoma;
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1;
* Have not received any anti-tumor treatment other than surgery in the past;
* Expected survival of more than 3 months;
* Possess sufficient organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to enrollment (no blood components, cell growth factors, albumin, or other corrective treatment drugs are allowed within 14 days prior to obtaining laboratory tests), as follows Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 100 g/L (no transfusion or erythropoietin dependence within 14 days) Liver function: serum total bilirubin ≤ 1.25 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 x ULN (≤ 5x ULN for patients with liver metastases); Serum albumin ≥ 30 g/L; Alkaline phosphatase (ALP) ≤ 5 × ULN.

Renal function: Serum creatinine (Cr) ≤ 1.25 × ULN, or creatinine clearance rate ≥ 60 mL/min (using the standard Cockcroft Gault formula): Urine routine results show urinary protein\<2+; For patients whose baseline urine routine test shows urinary protein ≥ 2+, 24-hour urine collection should be performed with a 24-hour urine protein quantification of\<1g.

Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the INR is within the intended range of use of the anticoagulant drug.

* For female subjects of childbearing age, a urine or serum pregnancy test should be conducted 3 days before receiving the first study drug and the result should be negative;
* The subjects and their sexual partners are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 6 months after the end of the study treatment period.

Exclusion Criteria:

* Previously received anti-tumor treatment other than surgery and radiation therapy for any malignant tumor;
* Subjects who cannot accept or tolerate this chemotherapy regimen for various reasons;
* Biopsy confirmed a patient with bone marrow infiltration;
* The patient has undergone significant surgical procedures unrelated to Ewing's sarcoma within the 4 weeks prior to enrollment, or has not fully recovered from such surgical procedures;
* Serious heart disease or discomfort, including but not limited to the following diseases:

Diagnosed history of heart failure or systolic dysfunction (LVEF\<50%); High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate\>100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block); Angina requiring treatment with anti angina drugs; Clinically significant heart valve disease; ECG shows transmural myocardial infarction; Poor control of hypertension (systolic blood pressure\>180mmHg and/or diastolic blood pressure\>100mmHg)

* Individuals with a known history of allergies to the components of this medication regimen;
* Breastfeeding female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study medication;
* The researchers believe that the patient is not suitable to participate in any other circumstances of this study.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cencer Center, — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xin Liu

Conditions Ewing Sarcoma; Myelosuppression; CDK4/6 inhibitor; Chemotherapy