se of romiplostim in children with cancers requiring high dose of chemotherapy, to accelerate platelet count recovery
Phase 2
- Conditions
- Health Condition 1: C920- Acute myeloblastic leukemiaHealth Condition 2: C762- Malignant neoplasm of abdomenHealth Condition 3: C419- Malignant neoplasm of bone and articular cartilage, unspecifiedHealth Condition 4: C499- Malignant neoplasm of connective and soft tissue, unspecifiedHealth Condition 5: C692- Malignant neoplasm of retinaHealth Condition 6: C859- Non-Hodgkin lymphoma, unspecified
- Registration Number
- CTRI/2023/02/049906
- Lead Sponsor
- Dr. SHIVAM BANSA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a) Cancer patient aged 1 to 14 year
b) Requires block-based myelosuppressive chemotherapy
c) First cycle of chemotherapy for solid tumors
d) Induction course 2 chemotherapy for acute myeloid leukemia
Exclusion Criteria
a) Presence of bony metastasis in solid tumors
b) Post induction course 1 chemotherapy, bone marrow not in complete remission or MRD more than 1% in AML
c) Received thrombopoietic agent in the past
d)Prior history of venous thromboembolism (VTE) or arterial thrombotic events
e) Subjects with non-consenting guardians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects achieving platelet count recovery (more than or equal to 1,00,000/microL and transfusion-free in the last 72 hours) within 3 weeks of enrolment, between children aged 1 to 14 years with cancer requiring myelosuppressive chemotherapy, and controlsTimepoint: Within 3 weeks of enrolment
- Secondary Outcome Measures
Name Time Method eed for platelet transfusionTimepoint: Within 3 weeks of enrolment;Rates of thrombotic eventsTimepoint: Within 3 months of romiplostim injection/ enrolment (in case of controls);Time taken for platelet recoveryTimepoint: Till platelet recovery;Bleeding ratesTimepoint: Within 3 weeks of enrolment;Chemotherapy dose delay (more than or equal to 4 days) or dose reduction (more than or equal to 15%)Timepoint: For the subsequent cycle of chemotherapy;Depth of platelet nadirTimepoint: Within 3 weeks of enrolment;Grade 3/4 thrombocytopeniaTimepoint: Within 3 weeks of enrolment