COMPLETED

NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy

Conditions

Progressive Multifocal Leukoencephalopathy Absolute Lymphocyte Count safety and tolerability of NT-I7

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Progressive multifocal leukoencephalopathy (PML) is a brain infection. It is caused by a virus. PML can happen in people with a weakened immune system. PML is associated with cognitive and visual impairment as well as motor and speech disturbances. There is no treatment for PML. Researchers want to see if a new drug can help. Objective: To see if the drug NT-I7 can help increase lymphocyte numbers, which may help control PML infection. Eligibility: Adults ages 18 and older with PML who are enrolled in Protocol #13-N-0017. Design: Participants will be screened under Protocol #13-N-0017. Participants will have a 7-day inpatient stay, outpatient visits, and follow-up phone calls. Participants will have a medical history and physical exam. They will give urine samples. Blood will be drawn from an arm vein or through an intravenous (IV) catheter. Participants will get up to 3 doses of NT-I7. It will be given by injection into the muscle. Participants will have lumbar punctures ( spinal taps ). A thin needle will be inserted into the spinal canal in the lower back. Cerebrospinal fluid will be removed. X-ray may be used to guide the procedure. Participants will have magnetic resonance imaging (MRI) of the brain. The MRI scanner is a metal cylinder surrounded by a magnetic field. During MRIs, participants will lie on a table that slides in and out of the scanner. Soft padding or a coil will be placed around their head. They will get gadolinium, a contrast agent, through an IV catheter. Participation will last for 12 to 19 months. ...

Official Title

A Pilot Study of NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy

Quick Facts

Study Start:2021-05-05

Study Completion:2025-11-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04781309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adults (18 years of age or older) * Definite or Probable PML (2013 AAN Consensus Diagnostic Criteria) * CD4 and/or CD8 lymphopenia \<= 200 cells/dL that is not readily reversible within one month * Enrolled in 13-N-0017 * Ability to provide own consent at study entry * Ability to travel to NIH for study visits * Willingness to comply with all study procedures * If able to become pregnant or to father a child, patient must agree to commit to the use of a reliable/accepted method of birth control (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation, or vasectomy) for the duration of the study	* Age \< 18 years of age * Ongoing treatment with immune-suppressive medications (exception: topical steroid use and all forms of systemic steroids with durations less than 2 weeks) * History of immune-mediated disease affecting vital organ * Concurrent treatment with experimental therapies for PML that would interfere with or confound assessment of study outcomes * History of underlying autoimmune disease involving the CNS * Contraindication to any study procedures that would compromise ability to safely monitor the patient * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with study participation; or not in the best interest of the subject to participate, in the opinion of the treating investigator * Women who are pregnant or breastfeeding * Unwilling to have coded samples and/or data saved or used in other studies

Inclusion Criteria

Exclusion Criteria

* Adults (18 years of age or older)
* Definite or Probable PML (2013 AAN Consensus Diagnostic Criteria)
* CD4 and/or CD8 lymphopenia \<= 200 cells/dL that is not readily reversible within one month
* Enrolled in 13-N-0017
* Ability to provide own consent at study entry
* Ability to travel to NIH for study visits
* Willingness to comply with all study procedures
* If able to become pregnant or to father a child, patient must agree to commit to the use of a reliable/accepted method of birth control (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation, or vasectomy) for the duration of the study

* Age \< 18 years of age
* Ongoing treatment with immune-suppressive medications (exception: topical steroid use and all forms of systemic steroids with durations less than 2 weeks)
* History of immune-mediated disease affecting vital organ
* Concurrent treatment with experimental therapies for PML that would interfere with or confound assessment of study outcomes
* History of underlying autoimmune disease involving the CNS
* Contraindication to any study procedures that would compromise ability to safely monitor the patient
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with study participation; or not in the best interest of the subject to participate, in the opinion of the treating investigator
* Women who are pregnant or breastfeeding
* Unwilling to have coded samples and/or data saved or used in other studies

Contacts and Locations

Principal Investigator

Irene CM Cortese, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Irene CM Cortese, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-05

Study Completion Date2025-11-07

Study Record Updates

Study Start Date2021-05-05

Study Completion Date2025-11-07

Terms related to this study

Keywords Provided by Researchers

Absolute Lymphocyte Count
safety and tolerability of NT-I7

Additional Relevant MeSH Terms

Progressive Multifocal Leukoencephalopathy