Studio su blinatumomab più combinazione di farmaci per trattare la leucemia linfoblastica acuta in bambini e adolescenti

Baseline Assessment

After joining the study the Patient attends the hospital for baseline assessments. These include blood tests, bone‑marrow Examination and imaging studies to confirm the diagnosis and to record the initial disease status.

The results are used to assign the Patient to the appropriate risk Group and to plan the subsequent treatment phases.

Induction chemotherapy

The Patient receives the first phase of treatment, called induction, which aims to eliminate as many leukaemia cells as possible.

The following medicines are given according to the protocol Schedule:

Methotrexate: 5000 mg/m2 administered intravenously (through a vein) on the designated days;

Cyclophosphamide: 500 mg/m2 intravenously;

Vincristine: 2 mg intravenously;

Doxorubicin: 30 mg/m2 intravenously;

Cytarabine: 75 mg/m2 intravenously;

Dexamethasone: 10 mg/m2 taken orally (by mouth).

Mg/m2 means milligrams per square meter of body Surface area, a way to adjust the dose to the size of the Patient.

Response Evaluation

After the induction phase the Patient undergoes repeat laboratory tests and bone‑marrow Examination to evaluate how well the leukaemia has responded to the treatment.

The findings determine whether the Patient proceeds to the next phase of the protocol.

Reduced‑intensity post‑induction therapy with blinatumomab

Patients classified as standard‑risk receive a less intensive chemotherapy regimen combined with a single cycle of immunotherapy.

The medicines used in this phase include:

Blinatumomab: 28 µg (micrograms) given as a continuous intravenous infusion each day for 28 days;

Mercaptopurine: 100 mg/m2 taken orally each day;

Tioguanine: 60 mg/m2 taken orally each day;

Pegaspagase: 3750 iu (International units) administered intravenously as a single dose;

Recombinant l‑asparaginase (enrylaze): 50 mg/m2 intravenously according to the Schedule;

Dexamethasone: 10 mg/m2 taken orally on the days indicated by the protocol.

The reduced‑intensity chemotherapy may also include lower doses of the drugs listed in the induction phase, administered on fewer days.

Maintenance therapy

Following the post‑induction phase the Patient enters a long‑term maintenance period to keep the disease in remission.

Maintenance medicines are taken orally on a regular basis:

Mercaptopurine: 100 mg/m2 daily;

Tioguanine: 60 mg/m2 daily;

Dexamethasone: 10 mg/m2 on the scheduled days.

Periodic intravenous doses of pegaspagase and recombinant l‑asparaginase may be given according to the protocol Schedule.

Follow‑up and monitoring

Throughout the study the Patient attends regular follow‑up visits for clinical Examination, blood tests and imaging to monitor disease‑free survival.

Any side effects or complications are recorded and managed according to the study guidelines.

The duration of follow‑up continues until the end of the study period or until a relapse, a second malignancy, or death occurs.