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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000126-N

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Absolute Lymphocyte Count;
safety and tolerability of NT-I7

Recruitment Keyword(s)

None

Condition(s)

Progressive Multifocal Leukoencephalopathy

Investigational Drug(s)

NT-I7

Investigational Device(s)

None

Intervention(s)

Drug: NT-I7

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

INCLUSION CRITERIA:

-Adults (18 years of age or older)

-Definite or Probable PML (2013 AAN Consensus Diagnostic Criteria)

-CD4 and/or CD8 lymphopenia less than or equal to 200 cells/dL from any cause 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

EXCLUSION CRITERIA:

-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 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 participation for the full duration of the trial; 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 OF VULNERABLE PARTICIPANTS:

Selection will be equitable among eligible patients.

Inclusion of decisionally impaired adults:

Consent capacity is required at the time of enrollment to ensure that participants are able to fully express understanding of participation prior to starting this more than minimal risk protocol. The study question should be able to be answered by enrolling those that have consent capacity at the time of enrollment, thus maximizing the risk benefit ratio. At the time of enrollment, while participants have consent capacity, they will be asked to appoint a DPA for research and health care to be invoked if they subsequently lose consent capacity.

Patients with PML may lose consent capacity with disease progression, and such participants will be allowed to remain in the study. This is justified, given the study question cannot be answered without enrolling people with PML and there is the possibility of direct benefit. In addition, at the time of enrollment the participants had capacity, agreed to full participation, and chose a surrogate to speak on their behalf should they lose capacity. This participant appointed DPA will be invoked should it be determined the subject no longer has consent capacity.

Inclusion of employees:

NIH employees and staff will not be solicited for participation but will not be excluded if they express the desire to enroll. NIH staff and family members of study team members may be enrolled in this study as this population meets the study entry criteria. Employees and staff who participate in this protocol during work hours will be informed that they must obtain their supervisor s permission. Neither participation nor refusal to participate as a subject in the research will have an effect, either beneficial or adverse, on the participant s employment, training or position at NIH.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



Frances C. Andrada, C.R.N.P.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 5C101
10 CENTER DR
BETHESDA MD 20814
(301) 496-3825
andradaf@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04781309

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