Acute Lymphatic Leukemia Clinical Trial
— HIF-ALLOfficial title:
Longitudinal Investigation of Hippocampal Function and Morphology in ALL Patients Treated With Chemotherapy: A Monocentric, Interdisciplinary Pilot Study
| NCT number | NCT01111396 |
| Other study ID # | EK153052009 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | March 31, 2010 |
| Last updated | April 26, 2010 |
| Start date | February 2010 |
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.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 40 Years |
| Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Dresden University of Technology University Hospital | Dresden |
| Lead Sponsor | Collaborator |
|---|---|
| Technische Universität Dresden | Martin-Luther-Universität Halle-Wittenberg |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hippocampal function measured with virtual water maze test | 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. | day 0 | No |
| Primary | Hippocampal function measured with virtual water maze test | 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. | day 9 | No |
| Primary | Hippocampal function measured with virtual water maze test | 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. | day 16 | No |
| Primary | Hippocampal function measured with virtual water maze test | 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. | day 52 | No |
| Primary | Hippocampal function measured with virtual water maze test | 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. | day 70 | No |
| Primary | Hippocampal function measured with virtual water maze test | 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. | week 36 | No |
| Secondary | Hippocampal morphology measured by MRI | day 0 | No | |
| Secondary | Hippocampal morphology measured by MRI | day 29 | No | |
| Secondary | Hippocampal morphology measured by MRI | day 70 | No | |
| Secondary | Hippocampal morphology measured by MRI | week 36 | No | |
| Secondary | Peripheral blood cell count | 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. |
day 0 | Yes |
| Secondary | Peripheral blood cell count | 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. |
day 26 | Yes |
| Secondary | Peripheral blood cell count | 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. |
day 46 | Yes |
| Secondary | Peripheral blood cell count | 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. |
day 71 | Yes |
| Secondary | Peripheral blood cell count | 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. |
week 16 | Yes |
| Secondary | Peripheral blood cell count | 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. |
week 22 | Yes |
| Secondary | Peripheral blood cell count | 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. |
week 30 | Yes |
| Secondary | Peripheral blood cell count | 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. |
week 41 | Yes |
| Secondary | Peripheral blood count | 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. |
week 52 | Yes |
| Secondary | Bone marrow examination | 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. |
day 0 | Yes |
| Secondary | Bone marrow examination | 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. |
day 26 | Yes |
| Secondary | Bone marrow examination | 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. |
day 46 | Yes |
| Secondary | Bone marrow examination | 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. |
day 71 | Yes |
| Secondary | Bone marrow examination | 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. |
week 16 | Yes |
| Secondary | Bone marrow examination | 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. |
week 22 | Yes |
| Secondary | Bone marrow examination | 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. |
week 30 | Yes |
| Secondary | Bone marrow examination | 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. |
week 41 | Yes |
| Secondary | Bone marrow examination | 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. |
week 52 | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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