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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-25

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients on Oncospar

Group Type EXPERIMENTAL

Asparaginase

Intervention Type DRUG

Measurement of serum Asparaginase activities during therapy, in terms of intensity and duration, as surrogate parameter for asparaginase depletion.

Interventions

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Asparaginase

Measurement of serum Asparaginase activities during therapy, in terms of intensity and duration, as surrogate parameter for asparaginase depletion.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No