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NCT Number: NCT04954326

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)

The purpose of this study is to compare the pharmacokinetics (PK) of both lyophilized and liquid S95014 formulations during the induction phase after a single IV dose in newly diagnosed paediatric patients with ALL

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Regional Children Clinical Hospital, Chelyabinsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 1 to < 18 years
  • Patients with cytologically confirmed and documented newly diagnosed ALL according to National Comprehensive Cancer Network guidelines 2020 (see Appendix 2), excluding B-cell Burkitt ALL
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 (see Appendix 3)
  • Highly effective contraception method
  • Signed informed consent and assent, when appropriate

Non-inclusion Criteria:

  • Unlikely to cooperate in the study
  • Pregnant and lactating women
  • Participation in another interventional study at the same time; participation in non-interventional registries or epidemiological studies is allowed
  • Participant already enrolled in the study (informed consent signed)
  • Women of childbearing potential tested positive in a serum pregnancy test within 7 days prior to the treatment period
  • Inadequate hepatic function (bilirubin > 1.5 times upper limit of normal (ULN), transaminases > 5x ULN)
  • Inadequate renal function defined as serum creatinine > 1.5 x ULN
  • Prior treatment with chemotherapy or radiotherapy (except steroids and intrathecal therapy)
  • Prior surgery or bone marrow transplant related to the studied disease
  • Down Syndrome
  • Psychiatric illness/social situation that would limit compliance with study requirements
  • Known history of pancreatitis
  • Known history of significant liver disease
  • Known carriers of HIV antibodies
  • Significant laboratory abnormality likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion
  • Pre-existing known coagulopathy (e.g. haemophilia and known protein S deficiency)
  • History of previous or concurrent malignancy
  • History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs
  • Severe or uncontrolled active acute or chronic infection
  • Uncontrolled intercurrent illness including life-threatening acute tumor lysis syndrome (e.g. with renal failure), symptomatic congestive heart failure, cardiac arrhythmia

Treatment and study plan

Lyophilized S95014

Drug

Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.

Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.

Liquid S95014

Drug

Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.

Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.

Primary outcomes

  1. Pharmacokinetics Measurement

    Time frame: Predose up to 600 hours

    Area Under the Plasma Asparaginase activity - Time curve from Time zero to infinity (AUCinf)

  2. Pharmacokinetics Measurement

    Time frame: Predose up to 600 hours

    Maximum observed plasma asparaginase activity (Cmax)

Secondary outcomes

  1. Pharmacokinetics Measurements

    Time frame: 14 days post-dose

    Observed Plasma Asparaginase Activity 14 days post-dose (Cday 14) of S95014

  2. Activity Measurement

    Time frame: Day 7, 14, 18 and 25 post-dose of either liquid or lyophilized S95014

    Plasma Asparaginase Activity (PAA) of ≥ 0.1 U/mL after the administration of either liquid or lyophilized S95014.

  3. Immunogenicity Measurements

    Time frame: Pre-dose, post-dose (sum of 14 and 25 days post-dose)

    Anti-drug antibodies (ADA) formation against S95014 and anti-PEG with the lyophilized or liquid formulations (positive patients).

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company
  • Les Laboratoires Servier (L.L.S), Russia

Registry information

Official study title

A Multicentre, Phase II Randomized Study, Open-label, With 2-arm Parallel Group, Comparing the Pharmacokinetics of the Liquid and the Lyophilized Formulations of Pegaspargase (S95014) in Treatment of Paediatric Patients With Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL)

Acronym: ALL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2021
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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