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START Pediatrics

R&D  /  Clinical Trials  /  START Pediatrics

Clinical Trials

The Pediatric Hematology and Oncology Unit actively participates in Phase I and Phase II–IV clinical trials as part of its commitment to therapeutic innovation and the development of new treatment strategies. All studies are conducted under regulated protocols and ethical oversight, ensuring patient safety at all times.

Currently Recruiting

Phase II

  • LuPARPed. Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for recurrent or relapsed solid tumors expressing somatostatin receptor (SSTR) (LuPARPed). NCT06607692.
    Eligible patients:
    • ≤ 18 years at diagnosis, no upper age limit at enrollment
    • Relapsed/refractory tumors expressing somatostatin receptors: HGG, meningioma, medulloblastoma, neuroblastoma, lymphomas, paraganglioma, pheochromocytoma, osteosarcoma…
    • Treatment with Lutathera + olaparib

    For more information: clinicaltrials.gov/study/NCT06607692
    Dr. Marta Osuna (Principal Investigator) – marta.osuna@startmadrid.com
  • TPX-0005-07. A study of repotrectinib in pediatric and young adult subjects harboring ALK, ROS1 or NTRK1-3 alterations. NCT04094610.
    Eligible patients:
    • Children, adolescents, and young adults up to 25 years of age
    • Tumors with:
      • NTRK fusion previously treated with one or two prior NTRK inhibitor lines
      • ROS1 fusion in first or subsequent lines of therapy
    • Treatment with repotrectinib

    For more information: clinicaltrials.gov/study/NCT04094610
    Dr. Marta Osuna (Principal Investigator) – marta.osuna@startmadrid.com
  • I3Y-MC-JPEH. Abemaciclib + temozolomide vs temozolomide in high-grade glioma following radiotherapy. NCT06413706.
    Eligible patients:
    • Children, adolescents, and young adults up to 21 years of age
    • Newly diagnosed high-grade glioma after radiotherapy
    • 1:2 randomization: temozolomide vs temozolomide + abemaciclib

    For more information: clinicaltrials.gov/study/NCT06413706
    Dr. Marta Osuna (Principal Investigator) – marta.osuna@startmadrid.com

Phase IV

  • LCH-IV. International protocol for Langerhans Cell Histiocytosis. EudraCT 2011-001699-20.
    Eligible patients:
    • Age < 18 years
    • Langerhans Cell Histiocytosis (de novo or relapsed)
  • UMBRELLA PROTOCOL SIOP-RTSG 2016. EudraCT 2016-004180-39 (since 2019).
    Eligible patients:
    • Any age (renal carcinoma only < 18 years)
    • Newly diagnosed renal tumors: Wilms tumor, clear cell sarcoma, renal carcinoma, rhabdoid tumor, mesoblastic nephroma, other renal tumors
  • EpSSG NRSTS 2005. EudraCT 2005-001139-31.
    Eligible patients:
    • Age < 21 years
    • Localized non-rhabdomyosarcoma soft tissue sarcomas: synovial sarcoma, fibrosarcoma, malignant peripheral nerve sheath tumor, epithelioid sarcoma, leiomyosarcoma, clear cell sarcoma, liposarcoma, alveolar sarcoma, angiosarcoma, dermatofibrosarcoma protuberans, among others

Not Recruiting

Phase I

  • D3820C00016. Naloxegol in pediatric patients receiving opioid therapy. NCT02099591.
    Duration: 2014–2021.

Phase II

  • XM22-08. Lipegfilgrastim vs filgrastim in Ewing family tumors or rhabdomyosarcoma. EudraCT 2015-000087-34.
    Duration: 2015–2019.
  • A6301094. Dalteparin (Fragmin®) in pediatric venous thromboembolism. NCT00952380.
    Duration: 2016–2018.

Phase III

  • PHITT. Pediatric liver tumors (hepatoblastoma, hepatocellular carcinoma). EudraCT 2016-002828-85.
    Duration: 2018–2024.
  • 20120215. Blinatumomab vs standard chemotherapy in high-risk ALL in first relapse. NCT02393859.
    Duration: 2016–2022.
  • LINES. Low- and intermediate-risk neuroblastoma. NCT01728155.
    Duration: 2016–2022.
  • LINESG2. Localized resectable neuroblastoma. SIOPEN.
    Duration: 2004–2012.
  • SIOPEL 3. Pediatric liver tumors.
    Duration: 1998–2006.
  • SIOPEL 6. Sodium thiosulfate to reduce cisplatin-induced ototoxicity. NCT00652132.
    Duration: 2007–2017.
  • Inter-B-NHL ritux 2010. Rituximab in high-risk pediatric B-cell non-Hodgkin lymphoma. EudraCT 2010-019224-31. NCT01516580.
    Duration: 2012–2021.
  • B0661037. Anticoagulation in pediatric venous thromboembolism. NCT02464969.
    Duration: 2016–2024.

Phase IV and Academic Studies

  • HR-NBL-1. High-risk neuroblastoma. SIOPEN. Duration: 2002–2017.
  • PGA111081. Nelarabine in relapsed/refractory T-ALL. NCT00866671.
    Duration: 2008–2014.
  • SIOP PNET5. Standard-risk medulloblastoma (low- and intermediate-biological risk profiles).
    Duration: 2016–2022.
  • R-0014/18. Asparaginase monitoring in ALL (SEHOP-PETHEMA 2013).
    Duration: 2018–2019.

START Pediatrics Unit

Phase I and Phase II–IV clinical trial activity is conducted through START Pediatrics, the Clinical Trials Unit integrated within START Madrid–CIOCC and the Pediatric Hematology and Oncology Department at HM Montepríncipe University Hospital.

More information about START Pediatrics