A Study of Romiplostim to Prevent Low Platelet Counts in Children and Young Adults Receiving Chem… (NCT04671901) | Clinical Trial Compass
TerminatedPhase 2
A Study of Romiplostim to Prevent Low Platelet Counts in Children and Young Adults Receiving Chemotherapy for Solid Tumors
Stopped: Lack of accrual
United States2 participantsStarted 2020-12-10
Plain-language summary
The purpose of this study is to find out whether romiplostim can help prevent low platelet counts caused by N8 or EFT chemotherapy, reduce the number of platelet transfusions required during chemotherapy, and prevent treatment delays due to low platelet counts.
Who can participate
Age range1 Year – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented diagnosis of a primary solid tumor. Patients must have histological verification of malignancy at MSKCC.
* Male and female patients aged 1-21 years with a primary solid tumor undergoing treatment with the pre-defined chemotherapy regimens of EFT, MAP, D9803. Prior to enrollment patient could have been undergoing induction therapy with a similarly myelosuppressive regimen as long as they will be continuing with EFT, MAP, D9803 at the time of study enrollment.
* Patients undergoing treatment with MAP chemotherapy w ho have had ≥ 1 platelet transfusion during induction stage of treatment.
* Total Bilirubin (sum of conjugated + unconjugated) ≤ 3 times institutional upper limit of normal (ULN) for age and ALT/AST ≤ 3 times institutional ULN for age.
* Normal cardiac function:
* Shortening fraction greater than or equal to 28% by echocardiogram OR Left ventricular ejection fraction (LVEF) greater than or equal to 50% on technetium- 99m pertechnetate radionuclide cineangiography (MUGA) or echocardiogram.
* Screening ECG with corrected QT (QTc) interval of \< 470 msec.
* Timing of cardiac assessment: We will utilize the most recent EKG/ECHO when assessing cardiac function. See section 9.0 for additional details.
* Adequate renal function, defined as an estimated Creatinine Clearance or GFR \>40ml/min or an normal creatine for age (see below)
Serum Creatinine by age:
Age (years) \<6: Maximum Serum Creatinine (mg/dL), Male 0.8, Female 0.8 Age …
What they're measuring
1
Total Number of Platelet Transfusions During the Studied Portions of the EFT or D9803 Cycles