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Use of the medicine eltrombopag to reduce bleeding in children with blood cancer

Efficacy and safety of oral eltrombopag in reduction of bleeding and platelet transfusion in pediatric acute lymphoblastic leukemia: A double blinded placebo-controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058321
Enrollment
60
Registered
2023-10-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: Oral eltrombopag: Oral eltrombopag, administered orally, according to the age group. •2-6 years: 25 mg/ day (1 tablet of 25 mg) •7-12 years: 50 mg/ day (2 tablets of 25 mg) •13-18 years

Sponsors

AIIMS, Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: SGOT/SGPT Normal cardiac and renal functions Written informed consent

Exclusion criteria

Exclusion criteria: a. Relapsed acute lymphoblastic leukemia and lymphoma b. Mixed phenotype acute leukemia c. Presence of hemodynamic compromise requiring vasoactive support at enrolment d. Presence of respiratory failure at enrolment e. Received therapy prior to presentation at treating centre (Excluding steroids up to 7 days) f. Hepatitis B/ C infection g. Known thrombophilia

Design outcomes

Primary

MeasureTime frame
1. Episodes and site of bleeding 2. Number and volume of platelet transfusionsTimepoint: End of induction chemotherapy (5 weeks) and end of consolidation chemotherapy (9 weeks)

Secondary

MeasureTime frame
Adverse effects associated with eltrombopag in patients with acute leukemiaTimepoint: End of induction chemotherapy (5 weeks) & end of consolidation chemotherapy (9 weeks);Complete remission rates & MRD negativity at end of inductionTimepoint: End of induction chemotherapy (5 weeks)

Countries

India

Contacts

Public ContactDEBASISH SAHOO

AIIMS, Bhubaneswar

debasish0712@gmail.com8872028232

Outcome results

None listed

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