FindTrial
Sign In

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.)

Indian Childhood Acute Promyelocytic Leukemia Study - I-ChAMPs

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065353
Enrollment
200
Registered
2024-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: C924- Acute promyelocytic leukemia

Interventions

Intervention1: NIL: NIL

Sponsors

Cankids, India [Srinivas Cankids APML Fund]
Lead Sponsor
Indian Pediatric Hemato Oncology Group INPHOG
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Efficacy outcome measures Complete Remission (CR) Induction event Treatment abandonment Molecular remission Relapse (molecular /hematologic) Survival -Leukemia free survival (LFS) Event free survival (EFS) Overall survival (OS)Timepoint: 5 Years.—

Secondary

MeasureTime frame
Toxicity measures NCI(National Cancer Institute) Common Terminology Criteria for Adverse Events (CTCAE)version 5.0 will be used to label & record Grade 3 /4 toxicities. Differentiation syndrome (DS): is a unique life-threatening complication of therapy with differentiating agents in APML. The diagnosis of DS is based on the clinical 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, respiratory failure, hypotension, fluid accumulations including pleural or pericardial effusions, or renal & hepatic dysfunction. It can be accompanied by hyperleukocytosis.Timepoint: Induction - Daily Consolidation - Monthly Maintenance - Three Monthly—

Countries

India

Contacts

Public ContactDr Smita Kayal

Jawaharlal Institute of Postgraduate Medical Education & Research

kayalsmita@gmail.com7598118439

Outcome results

None listed

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