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Neuroblastoma RecurrentPhase 2LuDO-NNCT04903899

177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma

A Phase 2 study testing 177Lu-DOTATATE in people with Neuroblastoma Recurrent and Neuroblastoma, run by Jakob Stenman at 5 sites in 5 countries.

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

The LuDO-N Trial is a multi-centre phase II clinical trial on 177Lu-DOTATATE treatment of recurrent or relapsed high-risk neuroblastoma in children. The LuDO-N Trial builds on the experience from the previous LuDO Trial and utilises an intensified dosing schedule to deliver 2 doses over a 2-week period, in order to… Read more about this study

Who is it for?
Ages 18 months and older
Conditions the study is for
Neuroblastoma Recurrent, Neuroblastoma
What is being tested?
177Lu-DOTATATE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
5 sitesin 5 countries
Study dates
19 May 2021to 20 May 2031
Phase
Phase 2
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 18 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Pathology 1.1. Histologically confirmed diagnosis of neuroblastoma 1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available
  • Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease
  • Age >18 months at the time of enrolment into this study
  • Life expectancy of greater than 3 months
  • Performance Status 5.1. Karnofsky > 50% (for patients > 12 years of age) 5.2. Lansky > 50% (for patients ≤ 12 years of age)
  • Prior treatment 6.1. Two-week washout from any prior treatment 6.2. Patients must have recovery of hematological toxicity following previous therapy 6.3. Adequate recovery from major surgery prior to receiving study treatment
Show all 10Show fewer
  • Diagnostic imaging 7.1. Uptake in the primary tumor or metastatic tumour deposits on 68Ga-DOTATATE PET/CT at least higher than the liver uptake and performed within two months prior to registration 7.2. 123I-mIBG scintigraphy to be performed within two months prior to registration 7.3. CT or MRI of the primary tumor and bulky metastatic sites within two months prior to registration
  • Laboratory requirements to be performed within 7 days prior to commencing trial treatment 8.1. Hematology: 8.1.1. Hemoglobin, If Hb is <120 g/L then patient will receive a blood transfusion prior to commencing trial treatment 8.1.2. Absolute neutrophil count > 1.0 x 109/L 8.1.3. Absolute Platelets > 50 x 109/L 8.2. Biochemistry: 8.2.1. Bilirubin within 1.5 x ULN 8.2.2. ALT within 2.5 x ULN 8.2.3. AST within 2.5 x ULN 8.2.4. GGT within 5 x ULN 8.2.5. ALP within 5 x ULN 8.2.6. Glomerular filtration rate >50mL/min/1.73m2 assessed by a recognised method, such as inulin, 51Cr-EDTA, 99mTc-DTPA or iohexol clearance and performed within 2 months prior to registration 8.2.7. Urinary catecholamine metabolites measured within 2 months prior to registration
  • Peripheral blood stem cells (PBSC) 9.1. A minimum of 2 x106 CD34+ cells/kg (optimally 6 x106 CD34+ cells/kg) must be available for each study subject prior to registration
  • Written informed consent from patient and/or parent(s) or legal guardian(s) in accordance with national regulations, prior to registration or any trial-related screening procedures

Who cannot join

  • Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the 177Lutetium-DOTATATE SmPC.
  • Pregnant or lactating patient
  • Concurrent treatment with any anti-tumor agents
  • Prior treatment with other radiolabeled somatostatin analogues
  • Hypersensitivity to any component of the investigational drug 177Lutetium-DOTATATE
  • Treatment with long-acting somatostatin analogues within 30 days, or with short-acting somatostatin analogues within 24 hours prior the administration of 177Lutetium-DOTATATE

Trial locations and contacts

5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Jakob Stenman, MD PhD contact

(0)51770000 ext. 46

jakob.stenman@sll.se

Kleopatra Georgantzi, MD contact

(0)51770000 ext. 46

kleopatra.georgantzi@sll.se

5 sites in 5 countries

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen, Copenhagen, DK-2100

    Jesper S Brok, MD PhD, jesper.sune.brok@regionh.dk

    Jesper S Brok, MD PhD

    Recruiting

Other trials in Denmark

Lithuania1 site, 1 recruiting

  • Vilnius University Hospital

    Vilnius, Vilnius County, LT-08406

    Jelena Rascon, MD PhD, jelena.rascon@gmail.com

    Jelena Rascon, MD PhD

    Recruiting

Other trials in Lithuania

Netherlands1 site, 1 recruiting

  • Princess Maxima Center for Pediatric Oncology

    Utrecht, Utrecht, NL-3584

    Max M van Noesel, MD PhD, M.M.vanNoesel@prinsesmaximacentrum.nl

    Max M van Noesel, MD PhD

    Recruiting

Other trials in Netherlands

Norway1 site, 1 recruiting

  • Oslo University Hospital, Rikshospitalet

    Oslo, Oslo, NO-0372

    Kirsten Brunsvig Jarvis, MD, kirjar@ous-hf.no

    Heidi Knudsen, MD

    Recruiting

Other trials in Norway

Sweden1 site, 1 recruiting

  • Karolinska University Hospital

    Stockholm, Stockholm County, SE-171 76

    Kleopatra Georgantzi, MD, kleopatra.georgantzi@sll.se

    Jakob Stenman, MD PhD, jakob.stenman@sll.se

    Recruiting

Other trials in Sweden

About this study

Official title: A Phase II Trial of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma

The LuDO-N Trial is a multi-centre phase II clinical trial on 177Lu-DOTATATE treatment of recurrent or relapsed high-risk neuroblastoma in children. The LuDO-N Trial builds on the experience from the previous LuDO Trial and utilises an intensified dosing schedule to deliver 2 doses over a 2-week period, in order to achieve a maximal effect on the often rapidly progressing disease. This strategy requires a readiness for autologous stem cell transplantation in all patients, but is not anticipated to increase the risk of long-term sequelae, since the cumulative radiation dose remains unchanged. The primary aim of the study is to assess the response to 177Lu-DOTATATE treatment at 1 and 4 months after ende of treatment. Secondary aims are to assess survival and treatment-related toxicity. Additional aim are to correlate tumour dosimetry with response, correlate SSTR-2 expression with 68Ga-DOTATATE uptake and to correlate the uptake with the treatment response.

Being tested
177Lu-DOTATATE
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-DOTATATECombination product

    A weight-based activity of 200 MBq kg-1 will be used for the first dose. The activity of the second dose will be calculated based on whole body activity scans as well as SPECT CT scans to determine the absorbed kidney dose. The aim is to administer 177Lu-DOTATATE corresponding to a whole-body dose of 1,2 Gy, with a cumulative whole-body dose of about 2,4 Gy over two courses, and not exceeding a cumulative renal dose of 23 Gy, in order to avoid renal toxicity.

Study groups in NCT04903899
Study groupRoleWhat they receive
177Lu-DOTATATEExperimentalA total of two doses of 177Lu-DOTATATE will be administered intravenously. The minimum time between treatments is 2 weeks.
Receives: Combination Product: 177Lu-DOTATATE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) - 1 months after End of Treatment

    Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)

    Measured: 1 months following end of treatment

Secondary outcomes (4)

  1. Number and severity of treatment-related adverse events

    Number and severity of treatment-related adverse events

    Measured: Up to 5 years after end of treatment

  2. Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) - 4 months after End of Treatment

    Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)

    Measured: 4 months following end of treatment

  3. Progression-free survival

    Time to progress or death, whichever occurs first

    Measured: Time from registration to progression or death, up to 5 years following end of treatment

  4. Overall survival - up to 5 years after End of Treatment

    Overall survival

    Measured: Time from registration to the the date of death, up to 5 years following end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start19 May 2021
  3. Primary completion20 May 2026 (estimated)
  4. Study completion20 May 2031 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04903899
Sponsor's protocol ID
LuDO-N
Acronym
LuDO-N
Status last verified
Mar 2024
First submitted
21 May 2021
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sundquist F, Georgantzi K, Jarvis KB, Brok J, Koskenvuo M, Rascon J, van Noesel M, Gryback P, Nilsson J, Braat A, Sundin M, Wessman S, Herold N, Hjorth L, Kogner P, Granberg D, Gaze M, Stenman J. A Phase II Trial of a Personalized, Dose-Intense Administration Schedule of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-Risk Neuroblastoma-LuDO-N. Front Pediatr. 2022 Mar 10;10:836230. doi: 10.3389/fped.2022.836230. eCollection 2022.

    PubMed 35359899

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 177Lu-DOTATATE in people with Neuroblastoma Recurrent and Neuroblastoma, run by Jakob Stenman at 5 sites in 5 countries.

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 10 inclusion and 6 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark, Lithuania, Netherlands, Norway, Sweden. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jakob Stenman, MD PhD ((0)51770000 ext. 46, jakob.stenman@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) - 1 months after End of Treatment (time frame: 1 months following end of treatment). 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 NCT04903899, which also lists 1 linked publication.

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 11 Feb 2025.

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