Children with ALL: Toxicity and Quality of Life Outcomes during Induction Chemotherapy
Not Applicable
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2023/08/055970
- Lead Sponsor
- Dr Antara Sanyal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Newly diagnosed case of acute lymphoblastic leukemia
2. Age 1-18 years
3. Treatment naïve
4. Diagnosis will be based upon the morphology and immunophenotype of the bone marrow aspirate/ peripheral blood sample
Exclusion Criteria
1.ALL <1 year of age or >18 years
2.Relapsed ALL, partially treated ALL
3.Burkittâ??s Leukemia
4.HIV, Hepatitis-B or Hepatitis-C positive cases
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the Grade three & Grade four toxicity during ALL induction chemotherapyTimepoint: Days 1 to 7 <br/ ><br>Days 8 to 14 <br/ ><br>Days 15 to 25 <br/ ><br>Days 26 to 35 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.To assess the quality of life at baseline & at the end of induction using the tool PedsQLâ?¢ 4.0 Generic Core (PedsQL-G) & PedsQLâ?¢ 3.0 Cancer Module (PedsQL-C); <br/ ><br>2.To correlate QoL to toxicity during induction treatment; <br/ ><br>3.To correlate post induction minimal residual disease (MRD) with baseline clinical characteristics & induction toxicities. <br/ ><br> <br/ ><br>Timepoint: At the beginning & end of induction chemotherapy