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A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) (ALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04956666
Recruitment Status : Recruiting
First Posted : July 9, 2021
Last Update Posted : September 20, 2021
Sponsor:
Collaborators:
ADIR, a Servier Group company
Les Laboratoires Servier (L.L.S), Russia
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Brief Summary:
The purpose of this study is to provide treatment with lyophilized S95014 in pediatric patients with ALL who completed the CL2-95014-002 study during the induction phase and who are clinically benefitting from S95014 without major toxicity.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Lyophilized S95014 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : November 7, 2022
Estimated Study Completion Date : November 7, 2022


Arm Intervention/treatment
Experimental: Lyophilized S95014

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.

Drug: Lyophilized S95014

Each patient will be administrated, over 1 to 2 hours, every 2 weeks Lyophilized S95014 intravenously at the dose of 1000, 2000 or 2500U/m2, as per investigator's judgement.

In total, 9 infusions of lyophilized S95014 will be administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients will receive other backbone chemotherapy agents as per ALL-MB 2015.





Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) (safety and tolerability) [ Time Frame: Through study completion, an average of 1 year ]
    All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0.



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who completed the CL2-95014-002 study
  • Patient currently receiving clinical benefit from previous treatment with S95014 as per investigator's judgment
  • Signed informed consent and assent, when appropriate
  • Highly effective contraception method

Non-inclusion Criteria:

  • Unlikely to cooperate in the study
  • Pregnant and lactating women
  • Participant already enrolled in the study (informed consent signed)
  • Prior surgery or bone marrow transplant related to the studied disease
  • History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs
  • Psychiatric illness/social situation that would limit compliance with study requirements
  • Group "E" and "T-HR" patients according to ALL-MB 2015 protocol classification
  • Major safety issue due to previous S95014 administration (e.g. non recovery of safety parameters, serious hypersensitivity, serious pancreatitis, serious haemorrhage, serious thromboembolic event)
  • Significant laboratory abnormality or uncontrolled intercurrent illness (e.g. life-threatening acute tumor lysis syndrome, symptomatic congestive heart failure, cardiac arrhythmia, severe or uncontrolled active acute infection) likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04956666


Contacts
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Contact: Institut de Recherches Internationales Servier Clinical Studies Department +33 1 55 72 43 66 clinical.trial.management@servier.com

Locations
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Russian Federation
Regional Children Clinical Hospital Not yet recruiting
Chelyabinsk, Russian Federation, 454087
Regional Children Clinical Hospital Not yet recruiting
Ekaterinburg, Russian Federation, 620149
Children Regional Clinical Hospital Not yet recruiting
Krasnodar, Russian Federation, 350007
Russian Children Clinical Hospital Not yet recruiting
Moscow, Russian Federation, 119571
Regional Children Hospital Recruiting
Nizhny Novgorod, Russian Federation, 603136
V.A. Almazov National Medical Research Center Not yet recruiting
Saint Petersburg, Russian Federation, 197341
Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
Les Laboratoires Servier (L.L.S), Russia
Investigators
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Principal Investigator: Alexander Isaakovich Karachunskiy, PhD Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT04956666    
Other Study ID Numbers: CL2-95014-003
2020-004895-17 ( EudraCT Number )
First Posted: July 9, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: https://clinicaltrials.servier.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Servier ( Institut de Recherches Internationales Servier ):
Acute Lymphoblastic Leukemia
Phase II
Oncology / Haematology
Continued treatment
Pegaspargase
Lyophilized pegaspargase
Roll-over study / extension study
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases