A multi-center study for children with blood cancer (acute lymphoblastic leukemia) for improving their survival.

ICiCLe-ALL-24 – The Indian Collaborative Childhood Leukaemia Randomised Trial for Children and Adolescents with Acute Lymphoblastic Leukaemia 2024 - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/069839

Enrollment

2567

Registered

2024-07-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: Split dexamethasone in induction (R1-B arm): Induction phase: Dexamethasone (PO) 6 mg/m2 in 2-divided doses, note that the maximum permitted dose is 12 mg daily. Intermittent dosing: Da

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed pediatric acute lymphoblastic leukemia or lymphoblastic lymphoma.

Exclusion criteria

Exclusion criteria: 1. Age less than 1 year 2. Age more than 18 years 3. Mature B-ALL 4. Down Syndrome 5. Mixed Phenotype Acute Leukaemia

Design outcomes

Primary

Measure	Time frame
Event free survival between the R1 and R2 randomisation arms.Timepoint: 3 years and 5 years from inclusion in study.	—

Secondary

Measure	Time frame
Event free survival in comparison to T-ALL cohort in ICiCLe-14 historical cohort. Timepoint: 3 years and 5 years from inclusion in study.;Overall survival, cummulative incidence of death, cummulative incidence of relapse and toxicity between the randomised arms and non randomised arms with historcial arms.Timepoint: 3 years and 5 years from inclusion in study.	—

Countries

India

Contacts

Public ContactVenkatraman Radhakrishnan

Cancer Institute (W.I.A)

venkymd@gmail.com9498082771

Outcome results

None listed

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