Use of romiplostim in children with cancers requiring high dose of chemotherapy, to accelerate platelet count recovery

Prophylactic romiplostim in pediatric subjects receiving myelosuppressive chemotherapy to hasten platelet recovery: An open-label randomized controlled trial - PROSPER

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049906

Enrollment

Registered

2023-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C920- Acute myeloblastic leukemia Health Condition 2: C762- Malignant neoplasm of abdomen Health Condition 3: C419- Malignant neoplasm of bone and articular cartilage, unspecified Health Condition 4: C499- Malignant neoplasm of connective and soft tissue, unspecified Health Condition 5: C692- Malignant neoplasm of retina Health Condition 6: C859- Non-Hodgkin lymphoma, unspecified

Interventions

Intervention1: Romiplostim along with standard of care: Romiplostim at a dose of 3 microgram/kg will be administered, two doses one week apart to intervention arm. The drug shall be administered via s

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Need 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	—

Measure

Time frame

Need 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

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Countries

India

Contacts

Public ContactDr ADITYA KUMAR GUPTA

AIIMS, NEW DELHI

adivick@gmail.com7838379837

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026