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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
1 Jul 2026to 31 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
Show all 9Show fewer
  • 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
Show all 26Show fewer
  • 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.

Axel Karow, PD. Dr. med. contact

09131 8533118

axel.karow@uk-erlangen.de

Ferdinand Knieling, Prof. Dr. med. contact

09131 8533118

ferdinand.knieling@uk-erlangen.de

Germany1 site, 1 recruiting

  • Department of Pediatrics and Adolescent Medicine

    Erlangen, 91054

    Recruiting

Other trials in Germany

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.

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 groups in NCT07705178
Study groupRoleWhat they receive
Control GroupOtherHealthy 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 leukemiaOtherSurvivors 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 lymphomaOtherSurvivors 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.

  1. Morphological lung changes (MRI)

    Morphological lung changes

    Measured: Single time point

  2. Functional lung parameters (MRI)

    Ventilation match/mismatch, Perfusion match/mismatch, combined defects

    Measured: Single time point

  3. Quantitative and functional cardiovascular changes (MRI)

    Quantitative and functional cardiovascular changes of the heart

    Measured: Single time point

Secondary outcomes (41)

  1. DLCO

    diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)

    Measured: Single time point

  2. VA

    Alveolar Volume

    Measured: Single time point

  3. KCO

    DLCO/VA (absolute and % of predicted value)

    Measured: Single time point

  4. VC

    VC (vital capacity) in %

    Measured: single time point

  5. FEV1

    FEV1 (Forced Expiratory Volume in 1 Second) in %

    Measured: Single time point

  6. VO2

    Oxygen uptake (VO2)

    Measured: Single time point

  7. VO2max

    peak oxygen uptake (VO2max)

    Measured: Single time point

  8. RER

    Respiratory exchange ratio (RER)

    Measured: Single time point

  9. VT2

    Ventilatory anaerobic threshold (VT2)

    Measured: Single time point

  10. VCO2

    Carbon dioxide output (VCO2)

    Measured: Single time point

  11. HR

    Heart rate (HR)

    Measured: Single time point

  12. HRR

    Heart Rate Reserve (HRR)

    Measured: Single time point

  13. Breath rate at VAT

    Breath rate at VAT

    Measured: Single time point

  14. BRR

    Breath rate reserve (BRR)

    Measured: Single time point

  15. VE

    minute ventilation (VE)

    Measured: Single time point

  16. O2 Pulse

    O2 Pulse

    Measured: Single time point

  17. HRV

    Heart rate variability (HRV)

    Measured: Single time point

  18. Borg Scale

    Exercise capacity (Borg Scale)

    Measured: Single time point

  19. Echocardiography

    Myocardial function by echocardiographic strain and strain-rate imaging

    Measured: Single time point

  20. Clinical parameters 1

    Age in years

    Measured: Single time point

  21. Clinical parameters 2

    Gender

    Measured: Single time point

  22. Clinical parameters 3

    Weight

    Measured: Single time point

  23. Clinical parameters 4

    Ethnicity

    Measured: Single time point

  24. Clinical parameters 5

    Time from therapy initiation/Interval until study day

    Measured: Single time point

  25. Clinical parameters 6

    Current medication*

    Measured: Single time point

  26. Clinical parameters 7

    Secondary diagnoses

    Measured: Single time point

  27. Blood pressure

    Blood pressure measurement

    Measured: Single time point

  28. Clinical examination

    Standard clinical examination

    Measured: Single time point

  29. Questionnaire regarding psychosocial aspects

    EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors

    Measured: Single time point

  30. Blood samples 1

    Presence of clonal hematopoiesis (CH)

    Measured: Single time point

  31. Blood samples 2

    Type of CH-associated gene mutations (e.g. DNMT3A, TET2, DDR genes)

    Measured: Single time point

  32. Blood samples 3

    Clone size / variant allele frequency (VAF)

    Measured: Single time point

  33. Blood samples 4

    Epigenetic aging markers (e.g. epigenetic age acceleration measures)

    Measured: Single time point

  34. Blood samples 5

    Telomere biology parameters (e.g. telomere length-related measures)

    Measured: Single time point

  35. Blood samples 6

    biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)

    Measured: Single time point

  36. MSOT 1

    Oxygenated haemoglobin (HbO₂)

    Measured: Single time point

  37. MSOT 2

    Deoxygenated haemoglobin (HHb)

    Measured: Single time point

  38. MSOT 3

    Total haemoglobin (tHb)

    Measured: Single time point

  39. MSOT 4

    Tissue oxygen saturation (sO₂)

    Measured: Single time point

  40. MSOT 5

    MSOT signal intensity per region of interest

    Measured: Single time point

  41. 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.

  1. First posted15 Jul 2026
  2. Study start1 Jul 2026
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

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)
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
Oct 2026
First submitted
9 Jul 2026
Last updated
30 Oct 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Axel Karow, PD. Dr. med. (09131 8533118, axel.karow@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphological lung changes (MRI) (time frame: Single time point). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07705178.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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