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

• Conditions: Acute Lymphatic Leukemia

• Registration Number: NCT01111396
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-31
• Status Verified: 2010-04
• Study First Submitted QC: 2010-04-26
• Last Update Submitted: 2010-04-26
• Study First Posted: 2010-04-27
• Last Update Posted: 2010-04-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hippocampal function measured with virtual water maze test	week 36	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

Name	Time	Method
Hippocampal morphology measured by MRI	week 36
Peripheral blood cell count	week 41	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	week 52	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	week 52	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.

Trial Locations

Locations (1)

Dresden University of Technology University Hospital; 🇩🇪 Dresden, Germany