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Trial Title:
Romiplostim in Chemotherapy-Induced Thrombocytopenia
NCT ID:
NCT06201663
Condition:
Chemotherapy-induced Thrombocytopenia
Solid Malignancy
Conditions: Official terms:
Neoplasms
Thrombocytopenia
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Romiplostim
Description:
Weekly subcutaneous injections
Arm group label:
Interventional group
Other name:
TPO-RA
Summary:
Prospective interventional randomized controlled trial to assess safety and efficacy of
romiplostim in chemotherapy-induced thrombocytopenia in children and adolescents with
solid malignancy
Detailed description:
Chemotherapy-induced thrombocytopenia (CIT) frequently complicates cancer treatment
causing delays in treatment and dose reduction for subsequent administration of
cancer-directed treatment.
Romiplostim is a potential agent that can improve platelet counts, allowing the
resumption of chemotherapy, decreasing the need for platelet transfusions, and increasing
the nadir platelet counts thus improving dose intensity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Age: 1- 18 years. Patients diagnosed with solid malignancy based on clinical,
histopathological features, and /or immunohistochemical staining.
Patients with chemotherapy-induced thrombocytopenia defined as either
- severe thrombocytopenia either clinically with high bleeding score or laboratory by
platelet count reaching critical level < 20x10e9/L requiring platelet transfusion at
time of chemotherapy cycle nadir.
- delayed recovery of platelet count: a platelet count of less than 100 x10e9/L for 3
weeks from the first day of chemotherapy cycle administration or the previous dose
was reduced by >20% due to low platelet count <100×10e9/L.
Exclusion Criteria:
- Patients with second primary neoplasm.
- Patients with relapsed/refractory solid malignancy.
- Presence of primary or metastatic liver cancer.
- History of a prior symptomatic venous thromboembolic event (VTE) or arterial
ischemic events.
- Patients with thrombocytopenia due to other etiologies e.g., underlying inherited
thrombocytopenia.
Gender:
All
Minimum age:
1 Year
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ain Shams University Children's Hospital
Address:
City:
Cairo
Zip:
11566
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Sara S Makkeyah, PhD
Phone:
+201140105222
Email:
smakkeyah@med.asu.edu.eg
Contact backup:
Last name:
Reem M El-Mazloom, MSc
Phone:
+201002488174
Email:
reem.mazloom@med.asu.edu.eg
Start date:
December 17, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06201663
