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

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ClinicalTrials.gov Identifier: NCT03668392
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Asparaginase Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 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 : June 25, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022


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.




Primary Outcome Measures :
  1. Number of patients with active serum Asparaginase [ Time Frame: After 8 months from study entry ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668392


Contacts
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Contact: Paola Fazi +39 06.70390521 p.fazi@gimema.it
Contact: Enrico Crea +39 0670390514 e.crea@gimema.it

Locations
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Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia Recruiting
Verona, Italy
Contact: Massimiliano Bonifacio         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Study Chair: Marco Vignetti Dipartimento di Biotecnologie Cellulari ed Ematologia - Università degli Studi "Sapienza" di Roma
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT03668392    
Other Study ID Numbers: ALL2518
2018-003517-17 ( EudraCT Number )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Asparaginase
Antineoplastic Agents