A Randomized Pilot Study on Central Nervous System (CNS) Prophylaxis

INTERVENTION: Trade Name: DEPOCYTE Pharmaceutical Form: Suspension for injection INN or Proposed INN: Cytarabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: METHOTREXATE Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Methotrexate Concentration unit: g gram(s) Concentration type: equal Concentration number: 1‐ Trade Name: ARACYTIN Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Cytarabine Concentration unit: mg/l milligram(s)/litre Concentration type: equal Concentration number: 100‐ Trade Name: URBASON Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Methylprednisolone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ CONDITION: 2. Diagnosis of untreated ALL with B‐/T‐precursor phenotype or B/T‐LL, either de novo or secondary to chemo‐radiotherapy for other cancer. ; MedDRA version: 9.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders PRIMARY OUTCOME: Main Objective: To evaluate comparatively toxicity and feasibility of intrathecal DepoCyte vs. triple intrathecal therapy, with a preliminary assessment of efficacy (randomized pilot study); to assess the outcome of patients treated with an updated lineage‐targeted and MRD/risk‐oriented induction/consolidation strategy. Primary end point(s): Feasibility: comparative analysis of feasibility of IT DepoCyte vs. TIT in conjunction with an early multidrug and multicycle consolidation regimen including lineage‐targeted systemic high‐dose methotrexate and cytarabine; Toxicity: comparative analysis of neuromeningeal toxicity during/after IT injections with DepoCyte vs. TIT, according to Common Toxicity Criteria (CTC) clinical scale and an ad hoc CNS toxicity evaluation protocol. Secondary Objective: CNS recurrence: comparative analysis of isolated and combined CNS recurrence following TIT vs DepoCyte prophylaxis in all patients and distinct risk subsets. INCLUSION CRITERIA: ALL Prospective Register 1. Age 18+ years. 2. Diagnosis of untreated ALL with B‐/T‐precursor phenotype or B/T‐LL, either de novo or secondary to chemo‐radiotherapy for other cancer. 3. Signed informed consent. Inclusion criteria 1. Age 18‐65 years. 2. Diagnosis of untreated ALL with B‐/T‐precursor phenotype or B‐cell lymphoblastic lymphoma (B‐LL), either de novo or secondary to chemo‐radiotherapy for other cancer. 3. Full cytological, cytochemical, cytogenetic and immunobiological disease characterization by revised FAB, EGIL and WHO criteria. 4. Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) for MRD study. 5. ECOG performance status 0‐2 or reversible ECOG 3 score following intensive care of complications. 6. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 E