Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy

Study Overview
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Brief Summary
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The purpose of this study is to learn about possible changes in brain anatomy and in thinking abilities, such as memory skills, in patients with cancer who receive treatment with chemotherapy alone or in combination with total body radiation before undergoing stem cell transplantation.

Official Title
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Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy

Conditions
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Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Undifferentiated Leukemia, Biphenotypic Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Procedure: MRI and cognitive evaluation
* Procedure: MRI and cognitive evaluation
* Procedure: brain MRI study and a brief neuropsychological evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), acute undifferentiated or biphenotypic leukemia, myelodysplastic syndrome (MDS), Hodgkin's lymphoma, (HL) or non-Hodgkin's lymphoma (NHL), and in complete remission at the time of enrollment Are scheduled to undergo conditioning treatment with (1) total body radiation (TBI) and chemotherapy or (2) chemotherapy alone prior to receiving a myeloablative allogeneic HSCT Between 18 and 70 years of age. Are English speaking. Have capacity to give consent. Healthy Control Inclusion Criteria: Have no diagnosis of cancer except basal cell carcinoma Between 18 and 70 years of age. Are English speaking. Have capacity to give consent Exclusion Criteria: Patients with signs and/or symptoms of central nervous system disease as determined by their physician or by a brain MRI, either at the time of enrollment or during the study period. With disease progression at the time of enrollment or during the study period With self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia With a history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness With standard contraindications to MRI examinations Healthy Control Exclusion Criteria: Exposure to chemotherapy or radiation therapy for any medical condition With self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia With a history of neurological disorders, neurodegenerative disease, or traumatic brain injury with loss of consciousness With standard contraindications to MRI examinations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>TBI and Chemotherapy Conditioning Regimen. Twenty (20) patients will undergo conditioning treatment with TBI and chemotherapy prior to receiving a myeloablative allogeneic or an autologous HSCT. | Procedure: MRI and cognitive evaluation<br>* Patients will undergo a brain MRI study and a brief neuropsychological evaluation, at the time of enrollment for controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients. A follow-up MRI and cognitive evaluation will be performed approximately 12 months after the transplant for patients.<br>|
| B<br>Chemotherapy Alone Conditioning Regimen Twenty (20) patients will undergo conditioning treatment with an all chemotherapy regimen prior to receiving an allogeneic or an autologous HSCT. | Procedure: MRI and cognitive evaluation<br>* Pt will undergo a Magnetic Resonance Imaging (MRI) study of the brain and a brief neuropsychological evaluation, at the time of enrollment for healthy controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients (Baseline/Time 1).<br>|
| C<br>A cohort of twenty (20) healthy controls, frequency matched on age, gender, and education, will be recruited at WCMC to participate in the study. | Procedure: brain MRI study and a brief neuropsychological evaluation<br>* A brain MRI study and a brief neuropsychological evaluation will be performed at baseline (Time 1). A follow-up MRI and cognitive evaluation will be performed and about 12 months after the baseline for healthy controls<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess changes in hippocampal volume & white matter integrity prospectively in adult ca pts who get treatment w/i chemotherapy alone or in combination with total body irradiation (TBI) before undergoing hematopoietic stem cell transplantation. |  | conclusion of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess memory and executive functions prospectively in these patients. We will investigate whether there is an association between structural brain changes and cognitive performance. |  | conclusion of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI