Longitudinal Investigation of Hippocampal Function and Morphology in Acute Lymphatic Leukemia (ALL) Patients Treated With Chemotherapy (HIF-ALL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Martin-Luther-Universität Halle-Wittenberg
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01111396
First received: March 31, 2010
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

There are two regions in the adult brain that exhibit neuronal stem and progenitor cells, generating new neurons postnatally and throughout adulthood. One is the so called subventricular zone the other is the dentate gyrus of the hippocampus. Adult neurogenesis is a physiological process representing an important functional impact for certain brain areas, especially the hippocampus. The hippocampal formation plays an important role in long-term memory and spatial navigation. Inhibition of adult neurogenesis in mice by chemotherapy or radiation is followed by significant deficits in hippocampal memory functions while hippocampus-independent memory is unaffected.

Clinical trials had shown that chemotherapy and brain radiation lead to cognitive dysfunction. However, the exact mechanisms underlying this phenomenon are still unidentified.

The aim of our study is to investigate, whether the inhibition of adult neural stem cell proliferation in the hippocampus by intrathecal chemotherapy and/or cerebral radiation is responsible for treatment induced memory deficits. We will investigate patients suffering from acute lymphatic leukaemia (ALL) that receive prophylactic intrathecal chemotherapy and brain irradiation. The study represents a longitudinal investigation including a virtual "humanized" version of the morris-water-maze to test hippocampus dependent spatial memory, as well as MR-imaging for morphological (volumetry) and biochemical (spectroscopy) data.


Condition
Acute Lymphatic Leukemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Longitudinal Investigation of Hippocampal Function and Morphology in ALL Patients Treated With Chemotherapy: A Monocentric, Interdisciplinary Pilot Study

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Hippocampal function measured with virtual water maze test [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.

  • Hippocampal function measured with virtual water maze test [ Time Frame: day 9 ] [ Designated as safety issue: No ]
    The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.

  • Hippocampal function measured with virtual water maze test [ Time Frame: day 16 ] [ Designated as safety issue: No ]
    The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.

  • Hippocampal function measured with virtual water maze test [ Time Frame: day 52 ] [ Designated as safety issue: No ]
    The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.

  • Hippocampal function measured with virtual water maze test [ Time Frame: day 70 ] [ Designated as safety issue: No ]
    The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.

  • Hippocampal function measured with virtual water maze test [ Time Frame: week 36 ] [ Designated as safety issue: No ]
    The hippocampal function will by studies in a longitudinal manner and thus we plan to measure the water maze test performance at several time points (time frames) of the study.


Secondary Outcome Measures:
  • Hippocampal morphology measured by MRI [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • Hippocampal morphology measured by MRI [ Time Frame: day 29 ] [ Designated as safety issue: No ]
  • Hippocampal morphology measured by MRI [ Time Frame: day 70 ] [ Designated as safety issue: No ]
  • Hippocampal morphology measured by MRI [ Time Frame: week 36 ] [ Designated as safety issue: No ]
  • Peripheral blood cell count [ Time Frame: day 0 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.


  • Peripheral blood cell count [ Time Frame: day 26 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.


  • Peripheral blood cell count [ Time Frame: day 46 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.


  • Peripheral blood cell count [ Time Frame: day 71 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.


  • Peripheral blood cell count [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.


  • Peripheral blood cell count [ Time Frame: week 22 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.


  • Peripheral blood cell count [ Time Frame: week 30 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.


  • Peripheral blood cell count [ Time Frame: week 41 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.


  • Peripheral blood count [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Peripheral blood cell counts for estimating the chemotherapy toxicity according to WHO criteria and the minimal residual disease activity.


  • Bone marrow examination [ Time Frame: day 0 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.


  • Bone marrow examination [ Time Frame: day 26 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.


  • Bone marrow examination [ Time Frame: day 46 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.


  • Bone marrow examination [ Time Frame: day 71 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.


  • Bone marrow examination [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.


  • Bone marrow examination [ Time Frame: week 22 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.


  • Bone marrow examination [ Time Frame: week 30 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.


  • Bone marrow examination [ Time Frame: week 41 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.


  • Bone marrow examination [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]

    Since we investigate a subpopulation of the GMALL 2003 chemotherapy study, all safety measures of the GMALL 2003 study are performed in the population of the present study.

    Bone marrow examination is investigated to extimate minimal residual disease activity and chemotherapy toxicity according to WHO criteria.



Estimated Enrollment: 10
Study Start Date: February 2010
Groups/Cohorts
Patient with ALL under chemotherapy
This group consists of patients with initial diagnosis of acute lymphatic leukemia (ALL), who are enrolled into the GMALL 2003 chemotherapy study. There is no change of the initial GMALL 2003 treatment protocol for the present study.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients of the Department of Internal Medicine at the Dresden University of Technology hospital, who are initially diagnosed of acute lymphatic leukemia (ALL) and included into the GMALL 2003 chemotherapy study. All treatment procedures and outcome measurements of the GMALL 2003 study (most importantly also the safety outcome measures) are regularly performed in the sub population of the present sub study. Inclusion and exclusion criteria are given below.

Criteria

Inclusion Criteria:

  • Initial diagnosis of acute lymphatic leukaemia (ALL)
  • Treatment within the German Multicenter Adult ALL (GMALL 2003) therapy study
  • Age 18 to 40 years
  • Eligibility for performing study procedure
  • Informed consent

Exclusion Criteria:

  • Neuropsychiatric disorders
  • Present contraindication for MRI investigation (e.g. pacemaker)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111396

Contacts
Contact: Moritz Brandt, MD +49-351-458 ext 18507 moritz.brandt@uniklinikum-dresden.de
Contact: Kalina Brandt, MD +49-351-458 ext 2610 kalina.brandt@uniklinikum-dresden.de

Locations
Germany
Dresden University of Technology University Hospital Recruiting
Dresden, Germany, 01307
Contact: Moritz Brandt, MD    +49-351-458 ext 18507    moritz.brandt@uniklinikum-dresden.de   
Contact: Kalina Brandt    +49-351-458 ext 2610    kalina.brandt@uniklinikum-dresden.de   
Sub-Investigator: Kalina Brandt         
Sub-Investigator: Moritz Brandt, MD         
Sub-Investigator: Martin Bornhaeuser, MD         
Principal Investigator: Alexander Storch, MD         
Sub-Investigator: Annett Werner, PhD         
Sub-Investigator: Markus Schaich, MD         
Sponsors and Collaborators
Technische Universität Dresden
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Alexander Storch, MD Technische Universität Dresden
  More Information

No publications provided

Responsible Party: Professor Alexander Storch, MD, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT01111396     History of Changes
Other Study ID Numbers: EK153052009
Study First Received: March 31, 2010
Last Updated: April 26, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
ALL
GMALL 2003
Chemotherapy
Hippocampus

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 22, 2014