A collaborative, multicentre, national study for newly diagnosed patients with acute lymphoblastic leukaemia

Randomised open label phase IV study for patients with newly diagnosed Acute Lymphoblastic Leukaemia (Indian Childhood Collaborative Leukaemia Group Study ALL 2014) - ICiCLe ALL-14

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/12/006434

Enrollment

2240

Registered

2015-12-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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] Health Condition 2: C910- Acute lymphoblastic leukemia [ALL] Health Condition 3: null- Childhood Acute Lymphoblastic Leukaemia

Interventions

Intervention1: Randomisation 1: 3 weeks of pulsed prednisolone during Induction for Standard Risk and Intermediate Risk B-Cell Precursor ALL Intervention2: Randomisation 2: One dose of Mitoxantrone du

Eligibility

Inclusion criteria

Inclusion criteria: Previously untreated newly-diagnosed ALL including T lymphoblastic lymphoma

Exclusion criteria

Exclusion criteria: Previously treated patients, patients with Down syndrome and patients with mature B-ALL

Design outcomes

Primary

Measure	Time frame
1.Event-free and Overall survival in all patients and within risk groups 2.Treatment toxicity in patients treated with 3 weeks of pulsed corticosteroid vs 5 weeks of continuous steroid during Induction in patients with Standard and Intermediate Risk B-Cell Precursor ALL (First randomisation) 3.Event-free and overall survival in patients treated with 1 dose of Mitoxantrone vs 3 doses of Doxorubicin during Delayed Intensification in all patients(Second Randomisation)Timepoint: At end of study and at 3 years from close of study	—

Measure

Time frame

1.Event-free and Overall survival in all patients and within risk groups 2.Treatment toxicity in patients treated with 3 weeks of pulsed corticosteroid vs 5 weeks of continuous steroid during Induction in patients with Standard and Intermediate Risk B-Cell Precursor ALL (First randomisation) 3.Event-free and overall survival in patients treated with 1 dose of Mitoxantrone vs 3 doses of Doxorubicin during Delayed Intensification in all patients(Second Randomisation)Timepoint: At end of study and at 3 years from close of study

—

Secondary

Measure	Time frame
1. Comparison of complete remission, minimal residual disease and survival (event-free and overall) outcomes between 2 arms in first randomisation 2. Comparison of treatment toxicity between two arms in second randomisationTimepoint: At end of study and at 3 years from close of study	—

Countries

India

Contacts

Public ContactDr Nandana Das

Tata Medical Center

vaskar.saha@tmckolkata.com03366057089

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 19, 2026