Oncaspar lyophilized (pegaspargase lyophilized) / Servier - LARVOL DELTA

Phase 2 multicenter study of pegaspargase in Japanese patients with previously untreated acute lymphoblastic leukemia. (PubMed, Int J Hematol) - "Plasma asparaginase activity reached ≥ 0.1 IU/ml 5 min after the first dose of lyophilized pegaspargase and was maintained for 14 days in all patients with evaluable samples. The results of this study show that lyophilized pegaspargase represents an effective and well-tolerated first-line treatment option in Japanese patients with ALL."

Clinical • Journal • P2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

COMPARISON OF THE PHARMACOKINETICS OF THE LIQUID AND THE LYOPHILIZED FORMULATIONS OF PEGASPARGASE IN THE TREATMENT OF PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) (EHA 2023) - "In summary, the results support the conclusion that the PK exposure of pegaspargase after IV administration at the dose of 2,500 U/m 2 does not depend on the drug formulation. Pharmacokinetics and safety results of this study are consistent with previously observed pegaspargase data. Pediatric, Pharmacokinetic, Acute lymphoblastic leukemia"

Clinical • PK/PD data • Acute Lymphocytic Leukemia • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Leukemia • Oncology • Pediatrics

A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov) - P2 | N=75 | Completed | Sponsor: Institut de Recherches Internationales Servier | Recruiting ➔ Completed

Trial completion • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

CL2-95014-002: A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov) - P2 | N=89 | Completed | Sponsor: Institut de Recherches Internationales Servier | Active, not recruiting ➔ Completed

Trial completion • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics

CL2-95014-002: A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov) - P2 | N=89 | Active, not recruiting | Sponsor: Institut de Recherches Internationales Servier | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics

A roll-over study to provide continued treatment with lyophilized pegaspargase (S95014) in Pediatric Patients with Acute Lymphoblastic Leukemia (ALL) (clinicaltrialsregister.eu) - P2; N=88; Sponsor: Institut de Recherches Internationales Servier

Clinical • New P2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

A study comparing the blood levels of both pegaspargase (S95014) formulations (liquid vs lyophilized) in the Treatment of Paediatric Patients with Acute Lymphoblastic Leukemia (ALL) (clinicaltrialsregister.eu) - P2; N=88; Sponsor: Institut de Recherches Internationales Servier

Clinical • New P2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics

CL2-95014-002: A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov) - P2; N=88; Recruiting; Sponsor: Institut de Recherches Internationales Servier

Clinical • New P2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics

A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov) - P2; N=88; Recruiting; Sponsor: Institut de Recherches Internationales Servier

Clinical • New P2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

Government allows import of acute lymphoblastic leukemia drug (Korea Biomedical Review) - "Servier Korea said it obtained the nod from the Ministry of Food and Drug Safety for importing Oncaspar as an orphan drug to be used in combination with other anti-cancer drugs when treating acute lymphocytic leukemia in children and adults under the age of 18."

Non-US regulatory • Acute Lymphocytic Leukemia • Hematological Malignancies • Oncology