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

Phase 2

Terminated

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Asparaginase

• Registration Number: NCT03668392
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Study Start: 2020-06-25
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients on Oncospar	Asparaginase	-

Primary Outcome Measures

Name	Time	Method
Number of patients with active serum Asparaginase	After 8 months from study entry

Trial Locations

Locations (7)

Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia; 🇮🇹 Roma, Italy

Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica; 🇮🇹 Ancona, Italy

Aso S. Croce E Carle - Cuneo - Sc Ematologia; 🇮🇹 Cuneo, Italy

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino; 🇮🇹 Torino, Italy

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2; 🇮🇹 Torino, Italy

Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia; 🇮🇹 Verona, Italy

Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica; 🇮🇹 Udine, Italy