Acute lymphoblastic leukemia (ALL) or malignant lymphoma-including lymphoblastic lymphoma (LBL)-regardless of whether newly diagnosed or recurrent.
Conditions
Interventions
None listed
Sponsors
Nara Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with ALL or malignant lymphoma, including LBL, who are receiving treatment with L-ASP and meet one of the following inclusion criteria while not meeting any of the following exclusion criteria Inclusion criteria: 1)Patients provided written consent to participate in the PEG-ASP24 study if they were 16 years of age or older, or consent was obtained from a legal guardian if the patient is younger. Recurrent cases are also eligible to participate. Regarding T-ALL cases, patients enrolled in the ALL-T19 study who have discontinued study treatment will be eligible (T-ALL in non-ALL-T19 enrolled cases will also be eligible). 2)If a patient meets (1) of the abovementioned criteria and is changing from PEG-ASP (or native E. coli-ASP) to Erw-ASP owing to allergic reaction or anaphylaxis, and if a patient has a blood sample for L-ASP activity and antibody measurement after the last dose of PEG-ASP (or native E. coli-ASP), the patient will be allowed to participate from that time onward.
Exclusion criteria
Exclusion criteria: 1)The principal investigator or research physician determines that participation in the PEG-ASP24 study is not appropriate. 2)Patients enrolled in the ALL-T19 trial with ongoing study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of SI in PEG-ASP-treated cases | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Frequency of SI in all cases treated with ASP products derived from E. coli (including native E. coli-ASP) since the introduction of PEG-ASP 2)Frequency of anti-L-ASP antibody production in Japan since the introduction of PEG-ASP 3)Proportion of cases with an L-ASP activity of <0.1 U/mL on day 21 after PEG-ASP administration 4)Frequency of allergic reactions and anaphylaxis for each formulation in cases treated with PEG-ASP, native E.coli-ASP, and Erw-ASP 5)Frequency of occurrence of decreased L-ASP activity and frequency of allergic reactions and anaphylaxis by age group 6)Changes in L-ASP activity and antibody titers before L-ASP formulation changes and after the last Erw-ASP dose due to allergic reactions and anaphylaxis 7)Correlation between the presence of anti-L-ASP antibodies and allergic reactions and anaphylaxis (CTCAE ver5.0) | — |
Countries
Japan
Contacts
Public ContactTakashi Ishihara
Nara Medical University Department of Pediatrics
Outcome results
None listed