Acute Lymphoblastic Leukemia
Conditions
Brief summary
In order to understand how pharmacokinetics and immunological inactivation affect the therapeutic efficacy of Asparaginase (ASP), it is of help and advised in the frame of clinical font-line protocols to monitor the enzymatic activity by measuring the serum ASP levels in the days following the administration of the drug.
Interventions
DRUGAsparaginase
Measurement of serum Asparaginase activities during therapy, in terms of intensity and duration, as surrogate parameter for asparaginase depletion.
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent according to ICH/EU/GCP and national local laws * Age 18 - 65 years * Diagnosis of untreated Ph- ALL entering treatment including PEG-ASP in induction and consolidation * ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by pre-existing comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures
Exclusion criteria
* Diagnosis of Burkitt's leukemia * Down's syndrome * Adults with Ph+ ALL * Pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, 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) * Kidney function impairment with serum creatinine \>2 mg/dL (unless attributable to ALL) * Severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan * Presence of serious, active, uncontrolled infections * Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is put off study. * Pregnancy * Men and women should use effective contraception during treatment and for at least 6 months after Asparaginase discontinuation. As a precautionary measure, breast-feeding should be discontinued during treatment with Asparaginase and should not be restarted after discontinuation of Asparaginase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with active serum Asparaginase | After 8 months from study entry |
Countries
Italy
Outcome results
None listed