A multicentre study to standardise the management of relapsed acute lymphoblastic leukaemia in children and young people

The Indian Paediatric Oncology Group collaborative multicentre treatment protocol for children and adolescents with relapsed acute lymphoblastic leukaemia (InPOG ALL R1) - InPOG ALL R1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021758

Enrollment

220

Registered

2019-10-22

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]

Interventions

Intervention1: A risk-adapted bortezomib and reduced intensity cytarabine-based modified ALL R3 treatment protocol for relapsed acute lymphoblastic leukaemia: Bortezomib in induction and reduced cumul

Eligibility

Inclusion criteria

Inclusion criteria: 1. Untreated first relapse of acute lymphoblastic leukaemia 2. Availability of clinical and laboratory information necessary for risk stratification 3. Consent to be treated on the study protocol

Exclusion criteria

Exclusion criteria: Inability to be treated with intensive chemotherapy on account of 1. unsuitable clinical status 2. prior adverse or dose-limiting treatment toxicity 3. prior maximum cumulative drug exposure; and/or 4. unsatisfactory organ function

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) for all patients and within risk groups. PFS is defined as the time from study entry to the first occurrence of progression, relapse, death from any cause or second malignancy.Timepoint: 5 years	—

Secondary

Measure	Time frame
Cumulative incidence of relapse and treatment-related deaths in the risk groups.Timepoint: 5 years.;Overall survival (OS) of patients treated on the study and patients who opt for non-curative management. OS is defined as the time from study entry to death from any cause.Timepoint: 5 years.;Proportion of patients stratified for blood stem cell transplantation (SCT) who are eventually treated with SCT.Timepoint: 4 years.;Proportion of relapsed ALL patients who consent to be treated on InPOG-ALL-R1.Timepoint: 4 years.;Rates of second complete remission and levels of minimal residual disease at the end of induction, consolidation and intensification phases of chemotherapy treatment.Timepoint: 4 years.;Toxicities associated with the different treatment phases in the study.Timepoint: 4 years.	—

Measure

Time frame

Cumulative incidence of relapse and treatment-related deaths in the risk groups.Timepoint: 5 years.;Overall survival (OS) of patients treated on the study and patients who opt for non-curative management. OS is defined as the time from study entry to death from any cause.Timepoint: 5 years.;Proportion of patients stratified for blood stem cell transplantation (SCT) who are eventually treated with SCT.Timepoint: 4 years.;Proportion of relapsed ALL patients who consent to be treated on InPOG-ALL-R1.Timepoint: 4 years.;Rates of second complete remission and levels of minimal residual disease at the end of induction, consolidation and intensification phases of chemotherapy treatment.Timepoint: 4 years.;Toxicities associated with the different treatment phases in the study.Timepoint: 4 years.

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Countries

India

Contacts

Public ContactDr Nandana Das

Tata Medical Center

vaskar.saha@tmckolkata.com03366057619

Outcome results

None listed

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