Ewing SarcomaPhase 2NCT06699472
A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib
A Phase 2 study testing Chemotherapy and Trilaciclib Injection [Cosela] in people with Ewing Sarcoma and Myelosuppression, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Ewing Sarcoma, Myelosuppression
- What is being tested?
- Chemotherapy and Trilaciclib Injection [Cosela]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2024to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cencer Center,
Shanghai, Shanghai Municipality, 200032
Zhiguo Luo, MD, 862164175590, luozhiguo88@163.com
About this study
Official title: 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 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.
- Conditions
- Ewing Sarcoma, Myelosuppression
- Being tested
- Chemotherapy, Trilaciclib Injection [Cosela]
- Keywords
- Ewing Sarcoma, Myelosuppression, CDK4/6 inhibitor, Chemotherapy
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called VDC/IE alternating chemotherapy
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 group | Role | What they receive |
|---|---|---|
| Chemotherapy+Trilaciclib | Experimental | 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. Receives: Drug: Chemotherapy; Drug: Trilaciclib Injection [Cosela] |
| Chemotherapy | Active comparator | 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. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of 4th degree neutropenia in the first treatment cycle
Measured: From enrollment to the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes (9)
The time for neutrophil count to recover to ≥ 0.5 × 10^9/L in the first treatment cycle
Measured: From enrollment to the end of Cycle 1 (each cycle is 21 days)
The incidence of febrile neutropenia during the first to fourth treatment cycles
Measured: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of grade 3 or higher neutropenia in the first to fourth treatment cycles
Measured: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of grade 3 or higher thrombocytopenia in the first to fourth treatment cycles
Measured: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of grade 3 anemia or above during the first to fourth treatment cycles
Measured: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The number of times and frequency of reduction of all cause chemotherapy drugs
Measured: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The number of cycles of the first reduction of chemotherapy drugs
Measured: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of infectious serious adverse events
Measured: From enrollment to the end of Cycle 4 (each cycle is 21 days)
EFS
Event Free Survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start31 Oct 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699472
- Sponsor's protocol ID
- 2409305-18
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Clinical Study on the Prevention of VDC/IE Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib
- ClinicalTrials.gov ID
- NCT06699472
- Acronym / sponsor ID
- 2409305-18
- Conditions
- Ewing Sarcoma, Myelosuppression
- Keywords
- Ewing Sarcoma, Myelosuppression, CDK4/6 inhibitor, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy+Trilaciclib | Experimental | Drug: Chemotherapy, Drug: Trilaciclib Injection [Cosela]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. |
| Chemotherapy | Active comparator | Drug: ChemotherapyReceive 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. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAlso: VDC/IE alternating chemotherapyVincristine (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 | Drug | Chemotherapy, Chemotherapy+Trilaciclib |
| Trilaciclib 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) | Drug | Chemotherapy+Trilaciclib |
Primary outcome
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)
9 secondary outcomes
The time for neutrophil count to recover to ≥ 0.5 × 10^9/L in the first treatment cycle
Time frame: From enrollment to the end of Cycle 1 (each cycle is 21 days)
The incidence of febrile neutropenia during the first to fourth treatment cycles
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of grade 3 or higher neutropenia in the first to fourth treatment cycles
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of grade 3 or higher thrombocytopenia in the first to fourth treatment cycles
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of grade 3 anemia or above during the first to fourth treatment cycles
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The number of times and frequency of reduction of all cause chemotherapy drugs
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The number of cycles of the first reduction of chemotherapy drugs
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of infectious serious adverse events
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
EFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy and Trilaciclib Injection [Cosela] in people with Ewing Sarcoma and Myelosuppression, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Liu (13761503356, jeanettexin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.