Acute Lymphatic LeukemiaMaximALLNCT07705178
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
A study testing QOL assessment, Neuropsychological, Spirometry and DLCO measurement in people with Acute Lymphatic Leukemia and Lymphoma, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
In this study, we investigate the cardiopulmonary health of survivors who underwent cancer treatment for acute lymphoblastic leukemia (ALL) or lymphoma during childhood, compared with healthy controls. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphatic Leukemia, Lymphoma
- What is being tested?
- QOL assessment, Neuropsychological, Spirometry and DLCO measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jul 2026to 31 Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- no cancer diagnosis
- no lung diseases
- no vascular diseases
- No subjective reduction in physical performance
- age >/= 18 years
- Completed therapy for ALL
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- age >/= 3 years
- Completed therapy for lymphoma
- age >/= 3 years
Who cannot join
- Pregnancy, Lactation
- Known pleural or pericardial effusion
- Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
- Marked thoracic deformities/malformations
- Previous lung surgery
- Injuries that do not allow physical stress diagnostics
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- Rejection of MRI imaging
- General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, copper IUD etc.)
- Survivors of ALL:
- Pregnancy, Lactation
- Known pleural or pericardial effusion
- Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
- Marked thoracic deformities/malformations
- Previous lung surgery
- Injuries that do not allow physical stress diagnostics
- Rejection of MRI imaging
- General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, copper IUD etc.)
- Survivors of Lymphoma:
- Pregnancy, Lactation
- Known pleural or pericardial effusion
- Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
- Marked thoracic deformities/malformations
- Previous lung surgery
- Injuries that do not allow physical stress diagnostics
- Rejection of MRI imaging
- General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, copper IUD etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Adolescent Medicine
Erlangen, 91054
About this study
Official title: "MaximALL" More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
In this study, we investigate the cardiopulmonary health of survivors who underwent cancer treatment for acute lymphoblastic leukemia (ALL) or lymphoma during childhood, compared with healthy controls. Modern imaging techniques (MRI, MSOT, and echocardiography) as well as questionnaires assessing cardiopulmonary and mental health are used.
Read the detailed description
Survivors of childhood cancer have a high risk of developing late effects regarding different organ systems even years after treatment. Our preliminary data show that a high number of our study participants who have received oncological treatment for ALL or Hodgkin's disease, develop severe ventilation and/or perfusion disorders/defects that can be detected on MRI of the lungs. These changes are mainly observed in participants with a greater interval to the oncological treatment and we could find a significant correlation between ventilation- and perfusion defects and the timespan after diagnosis. In spiroergometry, our patient group showed reduced aerobic capacity (ViO2 max), regardless of the time of follow-up. Echocardiography including strain analysis resulted in suspicious findings. The aim of our follow-up project is to validate these results in a larger patient population and to extend the investigations of long-term follow up after oncological disease/treatment in childhood and adolescence. We are planning to conduct a multicenter study with participants (who received oncological treatment in childhood or adolescence and are now undergoing long-term-follow-up care (> 5 years after treatment,). Therefore, we will examine morphological und functional lung changes by low field strength MRI and spiroergometry. We plan to investigate cardiac changes by echocardiography with strain analysis and ECG. Additionally, we would like to use multispectral optoacoustic tomography (MSOT) screening for muscle atrophy due to peripheral artery disease (PAD) as another modern imaging procedure for early detection of vascular changes.
- Conditions
- Acute Lymphatic Leukemia, Lymphoma
- Being tested
- QOL assessment, Neuropsychological, Spirometry, DLCO measurement, Echocardioraphy, MRI
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QOL assessment, NeuropsychologicalOther
QoL assessment by EORTC SURV100, PPR
SpirometryDiagnostic test
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurementDiagnostic test
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
EchocardioraphyDiagnostic test
Echocardiography with strain-rate imaging.
MRIDiagnostic test
LF-MRI for detection of morphological and functional changes in the lung and heart.
Clinical parametersOther
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
Blood samplesDiagnostic test
Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.
MSOTDiagnostic test
multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Healthy individuals with no previous cancer diagnosis. Volunteers will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart). Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) is performed. Receives: Diagnostic Test: Spirometry; Diagnostic Test: DLCO measurement; Diagnostic Test: Echocardioraphy; Diagnostic Test: MRI; Other: Clinical parameters |
| Survivors of leukemia | Other | Survivors of treatment for acute lymphatic leukemia in childhood or adolescence. Participants will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart). Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) and multispectral optoacoustic tomography (MSOT) for Peripheral artery disease (PAD) are performed. compliant data storage). In addition, venous blood samples will be taken for the analysis of molecular biomarkers. Receives: Other: QOL assessment, Neuropsychological; Diagnostic Test: Spirometry; Diagnostic Test: DLCO measurement; Diagnostic Test: Echocardioraphy; Diagnostic Test: MRI; Other: Clinical parameters; Diagnostic Test: Blood samples; Diagnostic Test: MSOT |
| Survivors of lymphoma | Other | Survivors of treatment for lymphoma in childhood or adolescence. Participants will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart). Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) and multispectral optoacoustic tomography (MSOT) for Peripheral artery disease (PAD) are performed. compliant data storage). In addition, venous blood samples will be taken for the analysis of molecular biomarkers. Receives: Other: QOL assessment, Neuropsychological; Diagnostic Test: Spirometry; Diagnostic Test: DLCO measurement; Diagnostic Test: Echocardioraphy; Diagnostic Test: MRI; Other: Clinical parameters; Diagnostic Test: Blood samples; Diagnostic Test: MSOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphological lung changes (MRI)
Morphological lung changes
Measured: Single time point
Functional lung parameters (MRI)
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
Measured: Single time point
Quantitative and functional cardiovascular changes (MRI)
Quantitative and functional cardiovascular changes of the heart
Measured: Single time point
Secondary outcomes (41)
DLCO
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
Measured: Single time point
VA
Alveolar Volume
Measured: Single time point
KCO
DLCO/VA (absolute and % of predicted value)
Measured: Single time point
VC
VC (vital capacity) in %
Measured: single time point
FEV1
FEV1 (Forced Expiratory Volume in 1 Second) in %
Measured: Single time point
VO2
Oxygen uptake (VO2)
Measured: Single time point
VO2max
peak oxygen uptake (VO2max)
Measured: Single time point
RER
Respiratory exchange ratio (RER)
Measured: Single time point
VT2
Ventilatory anaerobic threshold (VT2)
Measured: Single time point
VCO2
Carbon dioxide output (VCO2)
Measured: Single time point
HR
Heart rate (HR)
Measured: Single time point
HRR
Heart Rate Reserve (HRR)
Measured: Single time point
Breath rate at VAT
Breath rate at VAT
Measured: Single time point
BRR
Breath rate reserve (BRR)
Measured: Single time point
VE
minute ventilation (VE)
Measured: Single time point
O2 Pulse
O2 Pulse
Measured: Single time point
HRV
Heart rate variability (HRV)
Measured: Single time point
Borg Scale
Exercise capacity (Borg Scale)
Measured: Single time point
Echocardiography
Myocardial function by echocardiographic strain and strain-rate imaging
Measured: Single time point
Clinical parameters 1
Age in years
Measured: Single time point
Clinical parameters 2
Gender
Measured: Single time point
Clinical parameters 3
Weight
Measured: Single time point
Clinical parameters 4
Ethnicity
Measured: Single time point
Clinical parameters 5
Time from therapy initiation/Interval until study day
Measured: Single time point
Clinical parameters 6
Current medication*
Measured: Single time point
Clinical parameters 7
Secondary diagnoses
Measured: Single time point
Blood pressure
Blood pressure measurement
Measured: Single time point
Clinical examination
Standard clinical examination
Measured: Single time point
Questionnaire regarding psychosocial aspects
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
Measured: Single time point
Blood samples 1
Presence of clonal hematopoiesis (CH)
Measured: Single time point
Blood samples 2
Type of CH-associated gene mutations (e.g. DNMT3A, TET2, DDR genes)
Measured: Single time point
Blood samples 3
Clone size / variant allele frequency (VAF)
Measured: Single time point
Blood samples 4
Epigenetic aging markers (e.g. epigenetic age acceleration measures)
Measured: Single time point
Blood samples 5
Telomere biology parameters (e.g. telomere length-related measures)
Measured: Single time point
Blood samples 6
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
Measured: Single time point
MSOT 1
Oxygenated haemoglobin (HbO₂)
Measured: Single time point
MSOT 2
Deoxygenated haemoglobin (HHb)
Measured: Single time point
MSOT 3
Total haemoglobin (tHb)
Measured: Single time point
MSOT 4
Tissue oxygen saturation (sO₂)
Measured: Single time point
MSOT 5
MSOT signal intensity per region of interest
Measured: Single time point
MSOT 6
MSOT topogram of perfusion of the m. gastrocnemius
Measured: Single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start14 Jul 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphatic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferdinand Knieling, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705178
- Sponsor's protocol ID
- MaximALL
- Other IDs
- DKS 2025.17, 2026-03
- Acronym
- MaximALL
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw, individual and identifiable patient data are protected and are not available due to data privacy laws. Further data sets are planned to be shared