A study to check how good the children with relapsed Acute Lymphoblastic Leukemia (a type of blood cancer, which has returned) do when treated with chemotherapy that includes Mitoxantrone (a chemotherapeutic agent) for their treatment
Not Applicable
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2020/11/029373
- Lead Sponsor
- Dr Nirmalya Roy Moulik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Diagnosis of relapsed ALL
2)Age more than 15 years at the time of relapse of ALL
3)Treatment on TMH-R-ALL 2018 protocol
Exclusion Criteria
1) High risk relapse patients where HSCT is not feasible (due to social/financial/donor unavailability issues)
2) Patient getting palliated upfront.
3) Not consenting for enrolment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the 3-year event free survival (EFS) of children treated on TMH-R-ALL 18 protocol.Timepoint: End of each block of standard chemotherapy and after completion of the treatment, at 6 months for 3 years
- Secondary Outcome Measures
Name Time Method 1.To estimate the incidence and nature of severe (grade 3-4) toxicities during various phases (7 chemotherapy blocks and maintenance) of treatment. <br/ ><br>2.To estimate the proportion of patients clearing minimal residual disease (MRD) post block-1 chemotherapy in standard, intermediate and high risk groups. <br/ ><br>Timepoint: End of each block of standard chemotherapy and after completion of the treatment, at 6 months for 3 years