se of the medicine eltrombopag to reduce bleeding in children with blood cancer
Phase 2
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2023/10/058321
- Lead Sponsor
- AIIMS, Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
SGOT/SGPT < 3 times upper limit of normal and serum bilirubin < 2 mg/dL
Normal cardiac and renal functions
Written informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Episodes and site of bleeding <br/ ><br>2. Number and volume of platelet transfusionsTimepoint: End of induction chemotherapy (5 weeks) and end of consolidation chemotherapy (9 weeks)
- Secondary Outcome Measures
Name Time Method 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)