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出境医 / 临床实验 / Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL) (ALL2518)

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

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

Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Paola Fazi +39 06.70390521 p.fazi@gimema.it
Contact: Enrico Crea +39 0670390514 e.crea@gimema.it

Locations
Layout table for location information
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
Layout table for investigator information
Study Chair: Marco Vignetti Dipartimento di Biotecnologie Cellulari ed Ematologia - Università degli Studi "Sapienza" di Roma
Tracking Information
First Submitted Date  ICMJE September 11, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE June 25, 2020
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2018) 		Number of patients with active serum Asparaginase [ Time Frame: After 8 months from study entry ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL)
Official Title  ICMJE Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Lymphoblastic Leukemia
Intervention  ICMJE Drug: Asparaginase
Measurement of serum Asparaginase activities during therapy, in terms of intensity and duration, as surrogate parameter for asparaginase depletion.
Study Arms  ICMJE Experimental: Patients on Oncospar
Intervention: Drug: Asparaginase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2018) 		52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paola Fazi +39 06.70390521 p.fazi@gimema.it
Contact: Enrico Crea +39 0670390514 e.crea@gimema.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03668392
Other Study ID Numbers  ICMJE ALL2518
2018-003517-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Sponsor  ICMJE Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Marco Vignetti Dipartimento di Biotecnologie Cellulari ed Ematologia - Università degli Studi "Sapienza" di Roma
PRS Account Gruppo Italiano Malattie EMatologiche dell'Adulto
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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