Acute Lymphoblastic LeukemiaPhase 2ALLNCT04954326
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)
A Phase 2 study testing Lyophilized S95014 and Liquid S95014 in people with Acute Lymphoblastic Leukemia, run by Institut de Recherches Internationales Servier at 6 sites in Russia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Lyophilized S95014 and Liquid S95014
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 6 sitesRussia
- Study dates
- 7 May 2021to 20 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 26Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
Regional Children Clinical Hospital
Chelyabinsk, 454087
Children Regional Clinical Hospital
Krasnodar, 350007
Russian Children Clinical Hospital
Moscow, 119571
Regional Children Hospital
Nizhny Novgorod, 603136
V.A. Almazov National Medical Research Center
Saint Petersburg, 197341
Regional Children Clinical Hospital
Yekaterinburg, 620149
About this study
Official 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)
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
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Lyophilized S95014, Liquid S95014
- Keywords
- Oncology / Haematology, Phase II, Acute Lymphoblastic Leukemia, Parallel group, Pegaspargase, Pharmacokinetics comparability, Lyophilized pegaspargase, Liquid pegaspargase, Pegaspargase formulation, Randomized, open-label
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized S95014Drug
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 S95014Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| S95014 lyophilizate | Experimental | Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use. Receives: Drug: Lyophilized S95014 |
| S95014 liquid | Active comparator | Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use. Receives: Drug: Liquid S95014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Measurement
Area Under the Plasma Asparaginase activity - Time curve from Time zero to infinity (AUCinf)
Measured: Predose up to 600 hours
Pharmacokinetics Measurement
Maximum observed plasma asparaginase activity (Cmax)
Measured: Predose up to 600 hours
Secondary outcomes (3)
Pharmacokinetics Measurements
Observed Plasma Asparaginase Activity 14 days post-dose (Cday 14) of S95014
Measured: 14 days post-dose
Activity Measurement
Plasma Asparaginase Activity (PAA) of ≥ 0.1 U/mL after the administration of either liquid or lyophilized S95014.
Measured: Day 7, 14, 18 and 25 post-dose of either liquid or lyophilized S95014
Immunogenicity Measurements
Anti-drug antibodies (ADA) formation against S95014 and anti-PEG with the lyophilized or liquid formulations (positive patients).
Measured: Pre-dose, post-dose (sum of 14 and 25 days post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start7 May 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company, Les Laboratoires Servier (L.L.S), Russia
- Responsible party
- Sponsor
- Investigators
- Alexander Isaakovich Karachunskiy, PhD, Principal investigator, Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954326
- Sponsor's protocol ID
- CL2-95014-002
- Other IDs
- 2020-004894-29
- Acronym
- ALL
- Status last verified
- Jul 2023
- First submitted
- 18 Jun 2021
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04954326
- Acronym / sponsor ID
- ALL / CL2-95014-002
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Oncology / Haematology, Phase II, Acute Lymphoblastic Leukemia, Parallel group, Pegaspargase, Pharmacokinetics comparability, Lyophilized pegaspargase, Liquid pegaspargase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company, Les Laboratoires Servier (L.L.S), Russia
- Study start
- 7 May 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Posted 5 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S95014 lyophilizate | Experimental | Drug: Lyophilized S95014Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use. |
| S95014 liquid | Active comparator | Drug: Liquid S95014Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyophilized S95014Lyophilized 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. | Drug | S95014 lyophilizate |
| Liquid S95014Liquid 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. | Drug | S95014 liquid |
Primary outcome
Pharmacokinetics Measurement
Time frame: Predose up to 600 hours
Area Under the Plasma Asparaginase activity - Time curve from Time zero to infinity (AUCinf)
Pharmacokinetics Measurement
Time frame: Predose up to 600 hours
Maximum observed plasma asparaginase activity (Cmax)
3 secondary outcomes
Pharmacokinetics Measurements
Time frame: 14 days post-dose
Activity Measurement
Time frame: Day 7, 14, 18 and 25 post-dose of either liquid or lyophilized S95014
Immunogenicity Measurements
Time frame: Pre-dose, post-dose (sum of 14 and 25 days post-dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Find results on Servier Clinical Trial Data websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Isaakovich Karachunskiy, PhD principal investigator
Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lyophilized S95014 and Liquid S95014 in people with Acute Lymphoblastic Leukemia, run by Institut de Recherches Internationales Servier at 6 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics Measurement (time frame: Predose up to 600 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.