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
Conditions
Interventions
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:
Sponsors
NILG
Eligibility
Sex/Gender
All
Inclusion criteria
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 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diagnosis of B-ALL (FAB L3 ALL/Burkitt?s leukemia or lymphoma) and T-LL (T-cell lymphoblastic lymphoma). 2. Down?s syndrome. 3. Pre-existing, uncontrolled pathology such as cardiac disease (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrythmias, NYHA classes III and IV), severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL/LL), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL/LL), and severe neurological or psychiatric disorder that impairs the patient?s ability to understand and sign the informed consent, or to cope with the intended treatment plan. 4. Known HIV positive serology. 5. Other active hematological or non-hematological cancer with life expectancy <1 year. 6. Pregnancy (fertile women will be advised not to become pregnant while on treatment; and male patients to adopt contraceptive methods), unless therapeutic aborption/early discharge is carried out.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: CNS recurrence: comparative analysis of isolated and combined CNS recurrence following TIT vs DepoCyte prophylaxis in all patients and distinct risk subsets.;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. | — |
Countries
Italy
Outcome results
None listed