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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Terminated

CT.gov ID

NCT03668392

Collaborator

(none)

Enrollment

Locations

Arm

18.2

Actual Duration (Months)

Patient Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Asparaginase	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 25, 2020

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients on Oncospar	Drug: Asparaginase Measurement of serum Asparaginase activities during therapy, in terms of intensity and duration, as surrogate parameter for asparaginase depletion.

Arm

Intervention/Treatment

Experimental: Patients on Oncospar

Drug: Asparaginase

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

Outcome Measures

Primary Outcome Measures

Number of patients with active serum Asparaginase [After 8 months from study entry]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica	Ancona	Italy
2	Aso S. Croce E Carle - Cuneo - Sc Ematologia	Cuneo	Italy
3	Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia	Roma	Italy
4	Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino	Torino	Italy
5	Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2	Torino	Italy
6	Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica	Udine	Italy
7	Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia	Verona	Italy

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Study Chair: Marco Vignetti, Dipartimento di Biotecnologie Cellulari ed Ematologia - Università degli Studi "Sapienza" di Roma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gruppo Italiano Malattie EMatologiche dell'Adulto

ClinicalTrials.gov Identifier:

NCT03668392

Other Study ID Numbers:

ALL2518
2018-003517-17

First Posted:

Sep 12, 2018

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Asparaginase

Study Results

No Results Posted as of Mar 16, 2022