The aim of the study is to monitor the activity of Asparaginase, an enzyme that acts by degrading asparagine, an important component of proteins without which cells can not survive.Normal cells can produce asparagine independently, while some cancer cells are unable to do so. Asparaginase reduces the level of asparagine in the blood cells and stops the growth of cancer cells.

Phase 1

• Conditions: Adult patients, aged between 18 and 65, diagnosed with Acute Ph Lymphoblastic Leukemia negative (LAL Ph-) untreated, with a favorable impact on the prognosis.; MedDRA version: 21.0Level: LLTClassification code 10060390Term: Leukaemia lymphoblastic acuteSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-003517-17-IT
• Lead Sponsor: FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1) Signed written informed consent according to ICH/EU/GCP and national local laws
2) Age =18 – 65 years
3) Diagnosis of untreated Ph- ALL entering treatment including PEG-ASP in induction and consolidation
4) 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.
5) For females of childbearing potential and postmenopausal females, a negative pregnancy test must be documented at Screening.
6) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Diagnosis of Burkitt’s leukemia
2) Down’s syndrome
3) Adults with Ph+ ALL
4) 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)
5) Severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL)
6) Kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL)
7) Severe neuropsychiatric disorder that impairs the patient’s ability to understand and sign the informed consent, or to cope with the intended treatment plan
8) Presence of serious, active, uncontrolled infections
9) Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is put off study.
10) Pregnancy
11) Taking any medications or herbal supplements that are known to be strong inhibitors of enzymes or medications not allowed within at least 14 days before the first dose of Peg-Asp

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified