A study to keep a systematic watch over the treatment of the children and adolescent patients diagnosed with Chronic Myeloid Leukemia (CML) (a type of blood cancer) and to modify the frequency of treatment for the same
Not Applicable
- Conditions
- Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
- Registration Number
- CTRI/2020/11/029199
- Lead Sponsor
- Dr Nirmalya Roy Moulik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Age <15 years at the time of diagnosis of CML
2) Diagnosis of CML (Ph-positive)
Exclusion Criteria
1) Non-CML myeloproliferation
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Monitor response to TKI s (1st and 2nd generation). <br/ ><br> <br/ ><br>2)Prospectively monitor TKI toxicity (both short-term and long â??term). <br/ ><br>Timepoint: Every 3 Monthly OPD visit <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1)Ensure timely switch from 1st (imatinib) to 2nd generation TKI (nilotinib/dasatinib). <br/ ><br>2)Offer to interrupt TKI in good responders who satisfy stopping criteria and closely monitor them for molecular recurrence and resumption of treatment in case of recurrence. <br/ ><br>Timepoint: Every 3 Monthly OPD visit