Clinical trial · Interventional
Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL)
NCT03668392CI-TRIAL-00057149ALL2518terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low enrollment rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asparaginase | Drug | Asparaginase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients on Oncospar
- interventionNames
- Drug: Asparaginase
Primary outcomes (1)
- measure
- Number of patients with active serum Asparaginase
- timeFrame
- After 8 months from study entry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.