deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 4-arm NCT01228331

Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL

A Randomized Multi-Center Treatment Study (COALL 08-09) to Improve the Survival of Children with Acute Lymphoblastic Leukemia on Behalf of the German Society of Pediatric Hematology and Oncology

Sponsor: Universitätsklinikum Hamburg-Eppendorf

Conditions Leukemia
Interventions Amsacrine Clofarabine Cyclophosphamide Cytarabine Daunorubicin hydrochloride Dexamethasone Doxorubicin hydrochloride Etoposide phosphate Mercaptopurine Methotrexate Methylprednisolone Pegaspargase Thioguanine Vincristine sulfate Whole-brain radiation therapy
Updated 13 times since 2017 Last updated: Dec 5, 2024 Started: Oct 31, 2010 Primary completion: Dec 31, 2019 Completion: Nov 20, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01228331, this PHASE2/PHASE3 trial focuses on Leukemia and remains completed. Sponsored by Universitätsklinikum Hamburg-Eppendorf, it has been updated 13 times since 2010, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Jan 2019 · 6 months · monthly snapshot~Jan 2019 – ~Nov 2019 · 10 months · monthly snapshot~Nov 2019 – ~Apr 2020 · 5 months · monthly snapshot~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshot~Jan 2021 – ~Jun 2022 · 17 months · monthly snapshot~Jun 2022 – ~Feb 2024 · 20 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Sep 2025 · 8 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

13 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Jan 2025 — Sep 2025 [monthly]

    Completed PHASE2/PHASE3

    Status: Active Not Recruiting → Completed

  3. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE2/PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

  5. Feb 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2_PHASE3

▶ Show 8 earlier versions

  1. Jun 2022 — Feb 2024 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  2. Jan 2021 — Jun 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  3. Apr 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Nov 2019 — Apr 2020 [monthly]

    Recruiting PHASE2_PHASE3

  5. Jan 2019 — Nov 2019 [monthly]

    Recruiting PHASE2_PHASE3

  6. Jul 2018 — Jan 2019 [monthly]

    Recruiting PHASE2_PHASE3

  7. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2_PHASE3

  8. Jan 2017 — Jun 2018 [monthly]

    Recruiting PHASE2_PHASE3

    First recorded

Oct 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Universitätsklinikum Hamburg-Eppendorf
Data source: Universitätsklinikum Hamburg-Eppendorf

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Bielefeld, Germany , Bremen, Germany , Düsseldorf, Germany , Greifswald, Germany , Hamburg, Germany , Idar-Oberstein, Germany , Krefeld, Germany , Leipzig, Germany , Mainz, Germany , Munich, Germany and 3 more locations