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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)

Primary Purpose

Acute Lymphoblastic Leukemia

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

Lyophilized S95014

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Acute Lymphoblastic Leukemia, Phase II, Oncology / Haematology, Continued treatment, Pegaspargase, Lyophilized pegaspargase, Roll-over study / extension study

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Regional Children Clinical Hospital
Regional Children Clinical Hospital
Children Regional Clinical Hospital
Russian Children Clinical Hospital
Regional Children Hospital
V.A. Almazov National Medical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lyophilized S95014

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AEs) (safety and tolerability)

All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0.

Secondary Outcome Measures

Full Information

NCT ID

NCT04956666

First Posted

June 18, 2021

Last Updated

February 28, 2023

Sponsor

Institut de Recherches Internationales Servier

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04956666

Brief Title

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

Acronym

ALL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

June 15, 2021 (Actual)

Primary Completion Date

January 23, 2023 (Actual)

Study Completion Date

January 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut de Recherches Internationales Servier

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic Leukemia, Phase II, Oncology / Haematology, Continued treatment, Pegaspargase, Lyophilized pegaspargase, Roll-over study / extension study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lyophilized S95014

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lyophilized S95014

Intervention Description

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 Measure Information:

Title

Incidence of Adverse Events (AEs) (safety and tolerability)

Description

All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0.

Time Frame

Through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Isaakovich Karachunskiy, PhD

Organizational Affiliation

Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Regional Children Clinical Hospital

City

Chelyabinsk

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

Regional Children Clinical Hospital

City

Ekaterinburg

ZIP/Postal Code

620149

Country

Russian Federation

Facility Name

Children Regional Clinical Hospital

City

Krasnodar

ZIP/Postal Code

350007

Country

Russian Federation

Facility Name

Russian Children Clinical Hospital

City

Moscow

ZIP/Postal Code

119571

Country

Russian Federation

Facility Name

Regional Children Hospital

City

Nizhny Novgorod

ZIP/Postal Code

603136

Country

Russian Federation

Facility Name

V.A. Almazov National Medical Research Center

City

Saint Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

After Marketing Authorisation in EEA or US if the study is used for the approval.

IPD Sharing 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.

IPD Sharing URL

https://clinicaltrials.servier.com/

Links:

URL

https://clinicaltrials.servier.com/

Description

Find results on Servier Clinical Trial Data website

Available IPD and Supporting Information: