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Trial record 1 of 21 for:    "Non-Langerhans-Cell Histiocytosis" | "Immunologic Factors"
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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 : October 1, 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
Actual Study Start Date : July 2014
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:

  • None

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 Completed
Aurora, Colorado, United States, 80045-7106
United States, Georgia
Children's Healthcare of Atlanta Completed
Atlanta, Georgia, United States, 30329
United States, Massachusetts
Dana-Farber Cancer Institute (DFCI) Completed
Boston, Massachusetts, United States, 02115
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 Active, not recruiting
Cincinnati, Ohio, United States, 45229-3039
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Alexei Grom, MD    513-636-4676    alexi.grom@cchmc.org   
Principal Investigator: Alexei Grom, MD         
United States, Texas
Texas Children's Cancer Center Completed
Houston, Texas, United States, 77030
France
Hôpital Necker-Enfants Malades Not yet recruiting
Paris, France, 75743
Contact: Pierre Quartier Dit Maire, MD    33144494828      
Principal Investigator: Pierre Quartier Dit Maire, MD         
Germany
University Children's Hospital Münster Department of Pediatric Hematology and Oncology Completed
Münster, Germany, 48149
Italy
Iscss Istituto Giannina Gaslini Not yet recruiting
Genova, Italy, 16147
Contact: Angelo Ravelli, MD    +3901056362578      
Principal Investigator: Angelo Ravelli, MD         
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 Active, not recruiting
Rome, Italy, 00165
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 Completed
Verona, Italy, 37126
Spain
Hospital Universitario Vall d'Hebron Servei de Hematologia i Oncologia Completed
Barcelona, Spain, 08900
Hospital Sant Joan de Deu Recruiting
Esplugues De Llobregat, Spain, 08950
Contact: Jordi Anton, MD    +34932804000      
Principal Investigator: Jordi Anton, MD         
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 Recruiting
London, United Kingdom, WC1N 3JH
Contact: Paul Brogan, MD    020 7405 9200 ext 7887      
Principal Investigator: Paul Brogan, MD         
Great Ormond Street Hospital - Department of Haematology Active, not recruiting
London, United Kingdom, WC1N3JH
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: October 1, 2019
Last Verified: August 2019
Keywords provided by NovImmune SA:
Hemophagocytic lymphohistiocytosis (HLH) previously treated with NI-0501
Emapalumab
Additional relevant MeSH terms:
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Histiocytosis, Non-Langerhans-Cell
Immunologic Factors
Lymphohistiocytosis, Hemophagocytic
Histiocytosis
Lymphatic Diseases
Interferons
Interferon-gamma
Antibodies
Antibodies, Monoclonal
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents