Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy
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ClinicalTrials.gov Identifier: NCT00606216 |
Recruitment Status :
Completed
First Posted : February 1, 2008
Last Update Posted : December 10, 2015
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Condition or disease | Intervention/treatment |
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Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Acute Undifferentiated Leukemia Biphenotypic Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma | Procedure: MRI and cognitive evaluation Procedure: brain MRI study and a brief neuropsychological evaluation |
Study Type : | Observational |
Actual Enrollment : | 66 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Group/Cohort | Intervention/treatment |
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A
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.
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Procedure: MRI and cognitive evaluation
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. |
B
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.
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Procedure: MRI and cognitive evaluation
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). |
C
A cohort of twenty (20) healthy controls, frequency matched on age, gender, and education, will be recruited at WCMC to participate in the study.
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Procedure: brain MRI study and a brief neuropsychological evaluation
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 |
- 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. [ Time Frame: conclusion of the study ]
- assess memory and executive functions prospectively in these patients. We will investigate whether there is an association between structural brain changes and cognitive performance. [ Time Frame: conclusion of the study ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

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): NCT00606216
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
Weill Cornell Medical Center | |
New York, New York, United States |
Principal Investigator: | Denise Correa, PhD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00606216 |
Other Study ID Numbers: |
06-162 |
First Posted: | February 1, 2008 Key Record Dates |
Last Update Posted: | December 10, 2015 |
Last Verified: | December 2015 |
MRI |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Myelodysplastic Syndromes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases |
Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid |