Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL) (ALL2518)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status and phase

Terminated

Phase 2

Conditions

Acute Lymphoblastic Leukemia

Treatments

Drug: Asparaginase

Study type

Interventional

Funder types

Other

Identifiers

NCT03668392

2018-003517-17 (EudraCT Number)

ALL2518

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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