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Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody

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ClinicalTrials.gov Identifier: NCT02069899
Recruitment Status : Recruiting
First Posted : February 24, 2014
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Supported by a grant of the 7th framework programme "FP7" from the European Committee
Information provided by (Responsible Party):
NovImmune SA

Brief Summary:
International, multicenter, long-term, follow-up study that will enroll HLH patients who have received NI-0501 in a previous clinical trial, in the context of the clinical development program for NI-0501

Condition or disease Intervention/treatment Phase
Hemophagocytic Lymphohistiocytosis Drug: NI-0501 Not Applicable

Detailed Description:

The aim of this study is to monitor the long-term safety profile of patients who have previously received at least one dose of NI-0501, including survival at several time points after the administration of NI-0501.

Moreover to study the elimination profile of NI-0501 and to assess the immunogenicity of NI-0501.

Furthermore in the event that patients, upon request of the treating physician, will be maintained on NI-0501 treatment beyond the foreseen 8 weeks, NI-0501 safety, tolerability, efficacy and PK profile will be closely monitored in these patients until treatment discontinuation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicenter Study for the Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody
Study Start Date : June 2013
Estimated Primary Completion Date : September 2020


Arm Intervention/treatment
NI-0501 only in case is requested
NI-0501, in the event that, upon request of the treating physician, NI-0501 treatment needs to be prolonged beyond Week 8 foreseen in the previous protocol, patients will continue receiving NI-0501 in the context of this study.
Drug: NI-0501
In the event that NI-0501 treatment needs to be prolonged beyond Week 8 foreseen in the previous study, and upon request of the treating physician, patients will continue receiving NI-0501 in the context of this study.




Primary Outcome Measures :
  1. Safety Endpoints [ Time Frame: Up to 12 months post transplant or post last dose of NI-0501 ]

    The incidence, intensity, possible relationship to NI-0501 and outcomes of adverse events, serious and non-serious, will be assessed throughout the study.

    Vital signs, physical examination and laboratory values: evolution over time.



Other Outcome Measures:
  1. Efficacy endpoints [ Time Frame: Pre transplant, 30, 60, 100 days and 6, 12 months post transplant or post last dose of NI-0501 ]
    Survival

  2. Pharmacokinetics [ Time Frame: Up to 6 months after last NI-0501 infusion ]
    - NI-0501 elimination profile

  3. Pharmacodynamics [ Time Frame: Up to 6 months after last NI-0501 infusion ]
    • IFNγ total, as long as NI-0501 can be measured
    • IFNγ free, as soon as NI-0501 is not detectable
    • Exploratory parameters/disease markers

  4. Immunogenicity [ Time Frame: Up to 6 months after last NI-0501 infusion ]
    Presence of anti-drug antibodies (i.e. ADAs)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having received at least one dose of NI-0501.
  • Having signed the Informed Consent by the patient or the patient's legal representative(s), as applicable, with the assent of patients who are legally capable of providing it.

Exclusion Criteria:


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): NCT02069899


Contacts
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Contact: Cristina de Min, MD +41 61 201 1322 cdemin@novimmune.com

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045-7106
Contact: Timothy Garrington, MD    720-777-6740    timothy.garrington@childrenscolorado.org   
Principal Investigator: Timothy Garrington, MD         
United States, Delaware
Alfred I. duPont Hospital for Children Nemours Center for Cancer and Blood Disorders Recruiting
Wilmington, Delaware, United States, 19803
Contact: Jonathan Powell, MD    302-651-5500    Jonathan.Powell@nemours.org   
Contact: Debra Bertz       Debra.Bertz@nemours.org   
Principal Investigator: Jonathan Powell, MD         
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30329
Contact: Shanmuganathan Chandrakasan, MD    404-727-8877    shanmuganathan.chandrakasan@emory.edu   
Principal Investigator: Shanmuganathan Chandrakasan, MD         
United States, Massachusetts
Dana-Farber Cancer Institute (DFCI) Recruiting
Boston, Massachusetts, United States, 02115
Contact: Barbara A. Degar, MD    617-632-5186    Barbara_Degar@dfci.harvard.edu   
Principal Investigator: Barbara A Degar, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Completed
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital - Division of Immunobiology Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Michael Jordan, MD    513-636-7287    Michael.Jordan@cchmc.org   
Principal Investigator: Michael Jordan, MD         
United States, Texas
Texas Children's Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Carl Allen, MD, PhD    832-824-4312    ceallen@txch.org   
Contact: Linna Zhang    1-832-824-4592    lxzhang@txch.org   
Principal Investigator: Carl Allen, MD, PhD         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Mark N Fluchel, MD    801-662-4710    Mark.Fluchel@imail2.org   
Principal Investigator: Mark N Fluchel, MD         
Germany
University Children's Hospital Münster Department of Pediatric Hematology and Oncology Completed
Münster, Germany, 48149
Italy
Azienda Ospedaliera San Gerardo - Centro di Emato-Oncologia Pediatrica Completed
Monza, Italy, 20900
Azienda Ospedaliera Padova - Clinica di Oncoematologia Pediatrica Completed
Padova, Italy, 35128
Ospedale Pediatrico Bambino Gesu' Recruiting
Rome, Italy, 00165
Contact: Franco Locatelli, MD    0039 06 68592678    franco.locatelli@opbg.net   
Principal Investigator: Franco Locatelli, MD         
Ospedale Pediatrico Bambino Gesù - UO Reumatologia Recruiting
Rome, Italy, 00165
Contact: Fabrizio de Benedetti, MD    00 39 06 6859 2309 2659    fabrizio.debenedetti@opbg.net   
Principal Investigator: Fabrizio de Benedetti, MD         
Ospedale Donna Bambino - U.O.C. Oncoematologia Pediatrica Recruiting
Verona, Italy, 37126
Contact: Simone Cesare, MD    0039 045 812 7874    simone.cesaro@aovr.veneto.it   
Principal Investigator: Simone Cesare, MD         
Spain
Hospital Universitario Vall d'Hebron Servei de Hematologia i Oncologia Completed
Barcelona, Spain, 08900
Hospital Universitario Niño Jesús Servicio de Hemato-Oncología Pediátrica Completed
Madrid, Spain, 28009
Sweden
Karolinska University Hospital Completed
Stockholm, Sweden, 17176
United Kingdom
Great Ormond Street Hospital - Department of Haematology Recruiting
London, United Kingdom, WC1N3JH
Contact: Anupama Rao, MD         
Contact    00442074059200 ext 7918    Anupama.Rao@gosh.nhs.uk   
Principal Investigator: Anupama Rao, MD         
Sponsors and Collaborators
NovImmune SA
Supported by a grant of the 7th framework programme "FP7" from the European Committee

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Responsible Party: NovImmune SA
ClinicalTrials.gov Identifier: NCT02069899     History of Changes
Other Study ID Numbers: NI-0501-05
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: March 2018

Keywords provided by NovImmune SA:
Hemophagocytic lymphohistiocytosis (HLH) previously treated with NI-0501
Emapalumab

Additional relevant MeSH terms:
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Lymphohistiocytosis, Hemophagocytic
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases
Antibodies
Antibodies, Monoclonal
Interferons
Interferon-gamma
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents