I-ChAMPs - Pediatric APML Study(The purpose of the study is to facilitate the standard of care management to pediatric APMl patients pan India, and to develop a national registry for childhood APML with well annotated clinical data base.)
Not Applicable
- Conditions
- Health Condition 1: C924- Acute promyelocytic leukemia
- Registration Number
- CTRI/2024/04/065353
- Lead Sponsor
- Cankids, India [Srinivas Cankids APML Fund]
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
i. newly-diagnosed acute promyelocytic leukemia (APML) or medical records of patients with APML (for retrospective cohort)
ii. Age, 0-19 years
iii. signed written informed consent (waiver of consent for retrospective cohort)
Exclusion Criteria
With respect to the primary purpose of the registry no exclusion criteria are specified.
Explicitly patients with unsuitability for intensive therapy, pre –induction deaths should
also be recorded in the registry including patients who refuse treatment, for any reason.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy outcome measures <br/ ><br>Complete Remission (CR) <br/ ><br>Induction event <br/ ><br>Treatment abandonment <br/ ><br>Molecular remission <br/ ><br> Relapse (molecular /hematologic) <br/ ><br>Survival -Leukemia free survival (LFS) <br/ ><br>Event free survival (EFS) <br/ ><br>Overall survival (OS)Timepoint: 5 Years.
- Secondary Outcome Measures
Name Time Method Toxicity measures <br/ ><br>NCI(National Cancer Institute) Common Terminology Criteria for Adverse Events <br/ ><br>(CTCAE)version 5.0 will be used to label & record Grade 3 /4 toxicities. <br/ ><br>Differentiation syndrome (DS): is a unique life-threatening complication of therapy <br/ ><br>with differentiating agents in APML. The diagnosis of DS is based on the clinical <br/ ><br>presentation & setting (differentiation therapy for leukemia) & is supported by a response to treatment & exclusion of alternate diagnoses. Its presentation can be greatly varied & can include fever, peripheral edema, pulmonary infiltrates, <br/ ><br>respiratory failure, hypotension, fluid accumulations including pleural or pericardial effusions, or renal & hepatic dysfunction. It can be accompanied by hyperleukocytosis.Timepoint: Induction - Daily <br/ ><br>Consolidation - Monthly <br/ ><br>Maintenance - Three Monthly <br/ ><br>