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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia; Non-Hodgkin's Lymphoma; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Acute Undifferentiated Leukemia; Biphenotypic Leukemia
• Intervention / Treatment: Procedure: MRI and cognitive evaluation; Procedure: MRI and cognitive evaluation; Procedure: brain MRI study and a brief neuropsychological evaluation

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States
      • Weill Cornell Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be identified and recruited to participate in the study by Memorial Sloan-Kettering Cancer Center (MSKCC) and Weill Cornell Medical Center (WCMC).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; 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).
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.	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.; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Denise Correa, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 21, 2008
• First Submitted That Met QC Criteria: January 31, 2008
• First Posted (Estimate): February 1, 2008

Study Record Updates

• Last Update Posted (Estimate): December 10, 2015
• Last Update Submitted That Met QC Criteria: December 9, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: MRI
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Leukemia, Lymphoid; Myelodysplastic Syndromes; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: 06-162