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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

Treating children with relapsed ALL with mitoxantrone based protocol- A prospective observational study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/11/029373
Enrollment
500
Registered
2020-11-25
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: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Dr Nirmalya Roy Moulik
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. To estimate the incidence and nature of severe (grade 3-4) toxicities during various phases (7 chemotherapy blocks and maintenance) of treatment. 2. To estimate the proportion of patients clearing minimal residual disease (MRD) post block-1 chemotherapy in standard, intermediate and high risk groups. Timepoint: End of each block of standard chemotherapy and after completion of the treatment, at 6 months for 3 years

Countries

India

Contacts

Public ContactDr Nirmalya Roy Moulik

Tata memorial Hospital

roymoulik@gmail.com7045991385

Outcome results

None listed

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