Protocol Number: 08-H-0222

Title:

Neuropsychological Effects of Immunosuppressive Treatment in Subjects with Aplastic Anemia

Number:

08-H-0222

Summary:

This study will use neuropsychological tests to look at nervous system side effects of Cyclosporine (CsA) in patients with aplastic anemia. CsA is used as part of an immunosuppressive regimen in treating severe aplastic anemia. The drug can produce nervous system side effects, such as tremor and, less commonly, insomnia, anxiety, headache, confusion or seizures. This study will look at effects of CsA on intellectual ability, depression, anxiety, attention, concentration, memory, perception, coordination, and thought processing in patients

Patients 15 years of age or older who have severe aplastic anemia may be eligible for this study if they:

- are co-enrolled in a Clinical Center protocol in which they will receive CsA

- have not taken CsA for 6 months before enrolling in this study

Participants undergo neuropsychological testing. In addition, they provide blood samples and their clinical data are reviewed for things that may influence the interpretation of findings from the testing, such as results of blood tests, types of medications taken, number of transfusions required, etc. The procedures are as follows:

Before first dose of cyclosporine:

- Patients are asked about prior problems with their nervous system, prior treatment for their aplastic anemia (including transfusions), prior infections, and current medications. They then complete the following sets of tests:

- Battery 1: A set of three tests that measure intellectual ability, level of depression (if any) and level of anxiety (if any).

- Battery 2: A set of seven tests that measure changes in the central nervous system and how these changes affect attention, concentration, memory, perception, coordination, and thought processing.

- Patients provide a half teaspoon of blood for this study at the same time blood is collected for their primary treatment protocol.

6 months and 12 months after starting cyclosporine

- Patients are asked about treatment for their aplastic anemia (including transfusions), infections, and changes in medications that have occurred since they started taking cyclosporine. They then repeat the set of tests in Battery 2.

- Patients provide a half teaspoon of blood for this study at the same time blood is collected for their primary treatment protocol.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCULSION CRITERIA:

-Diagnosed with aplastic anemia.

-Co-enrolled on a Clinical Center CsA treatment protocol that prescribes CsA (included but not limited to 06-H-0034 (initial treatment cohort in both rabbit and horse ATG arm), 03-H-0249, 05-H-0242 and standard treatment protocol 94-H-0010).

-Age greater than or equal to 15 years old.

EXCLUSION CRITERIA:

-Prior use of cyclosporine within 6 months to next line of treatment.

-History of learning disability (i.e. dyslexia).

-Unable to read and speak English (the neuropsychological testing tools are validated for use in English speaking subjects only).

-Life expectancy less than six months or when clinical status prevents full performance with testing.

-Either adult patients or guardians for the minor patient, unable to comprehend the investigational nature of the study and provide informed consent.

-Inability or unwillingness to come to Clinical Center for the 6-month and 12-month follow-up appointments.

Special Instructions:

Currently Not Provided

Keywords:

Aplastic Anemia

Cyclosporine

Campath

Neurophyschological Side Effect

Recruitment Keyword(s):

Aplastic Anemia

Neurophyschological Side Effect

Condition(s):

Aplastic Anemia

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Heart, Lung, and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Young NS, Calado RT, Scheinberg P. Current concepts in the pathophysiology and treatment of aplastic anemia. Blood. 2006 Oct 15;108(8):2509-19. Epub 2006 Jun 15.

Gijtenbeek JM, van den Bent MJ, Vecht CJ. Cyclosporine neurotoxicity: a review. J Neurol. 1999 May;246(5):339-46.

Syrjala KL, Dikmen S, Langer SL, Roth-Roemer S, Abrams JR. Neuropsychologic changes from before transplantation to 1 year in patients receiving myeloablative allogeneic hematopoietic cell transplant. Blood. 2004 Nov 15;104(10):3386-92. Epub 2004 Jul 13.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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