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

Sponsor
Fudan University
Study ID
NCT06699472
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ewing Sarcoma
  • Myelosuppression

Eligibility Criteria

Sex
ALL
Age
14 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy — DRUG
    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
  • Trilaciclib Injection [Cosela] — DRUG
    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)

Study Details

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.

Key Dates

First listed
Nov 21, 2024
Start date
Oct 31, 2024
Status verified
Nov 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Chemotherapy+Trilaciclib
    Receive 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 and intolerable toxicity occur.
  • Active Comparator: Chemotherapy
    Receive VDC+IE alternating chemotherapy with 3 weeks as one course of treatment, for a total of 17 cycles or until disease progression and intolerable toxicity occur.

Primary Outcome Measure

Duration of 4th degree neutropenia in the first treatment cycle [ Time Frame: From enrollment to the end of Cycle 1 (each cycle is 21 days) ]

Central Contacts

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