Health Condition 1: C419- Malignant neoplasm of bone and articular cartilage, unspecified Health Condition 2: C410- Malignant neoplasm of bones of skull and face Health Condition 3: C402- Malignant neoplasm of long bones of lower limb Health Condition 4: C411- Malignant neoplasm of mandible Health Condition 5: C408- Malignant neoplasm of overlappingsites of bone and articular cartilage of limb Health Condition 6: C478- Malignant neoplasm of overlappingsites of peripheral nerves and autonomic ner
Conditions
Interventions
Intervention1: addition of romiplostim in the adjuvant chemotherapy setting: At 24 hours post finishing chemotherapy, a single dose of romiplostim will be administered along with G-CSF. [Day 4-6 of ch
If platelet count 75,000/ uL and IPF 20% to give a repeat dose of romiplostim Repeat platelet count check after 7 days [Day 18-20]
Control Intervention1: not applicable: not applicable
Sponsors
Manipal Academy of Higher education
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 1-18 years undergoing myelosuppressive therapy for sarcoma (Ewing sarcoma, Rhabdomyosarcoma, osteosarcoma) in the adjuvant setting (from cycle 4) 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
Exclusion criteria
Exclusion criteria: No parental consent Presence of bone marrow metastasis Previous use of romiplostim or eltrombopag for any indication Relapsed/refractory/progressive disease Secondary malignancy Inherited predisposition to myeloid stem cell disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe thrombocytopenia in adjuvant chemotherapy setting with romiplostim and comparison with historical controlTimepoint: At 3 weeks after each cycle of adjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| duration and nadir of platelet count with addition of romiplostimTimepoint: at d 11-13 and day 18-20 of each chemotherapy cycle;median number of doses of romiplostim required for preventing severe thrombocytopeniaTimepoint: end of each chemotherapy cycle;safety and incidence of side effectsTimepoint: at end of each chemotherapy cycle | — |
Countries
India
Contacts
Public ContactEmine Rahiman
Kasturba Medical College
Outcome results
None listed