A multicentre study to standardise the management of relapsed acute lymphoblastic leukaemia in children and young people
Phase 3
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2019/10/021758
- Lead Sponsor
- Tata Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.