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05-001: Treatment of Acute Lymphoblastic Leukemia in Children

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 53 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv53
  2. Study title expanded, about 1 wordv52 Show moreShow less

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  3. 2 versions Re-verified since Nov 22, 2024, no change to tracked fieldsv50-v51
  4. Study sites revised (8)v49 Show moreShow less

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  5. Study sites: 10 to 8v48
Show 44 earlier versionsHide 44 earlier versions
  1. 4 versions Re-verified since May 31, 2022, no change to tracked fieldsv44-v47
  2. Trial status: Active, Not Recruiting to Completedv43
  3. Completion date: Jun 2018 to Jun 2019v42
  4. Results first posted: Jun 14, 2017 Primary endpoint revised · Primary completion date changed from estimate of Jun 2015 to Aug 2014 · Completion date: Jun 2015 to Jun 2018 · 4 morev41 Show all 8 changesShow less
    • Primary endpoint revised
    • Primary completion date changed from estimate of Jun 2015 to Aug 2014
    • Completion date: Jun 2015 to Jun 2018
    • Eligibility criteria shortened, about 304 words
    • Secondary endpoints: 13 to 9
    • Study description expanded, about 438 words
    • Publications: details revised at 1 of 4 entries

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  5. Primary and study completion dates: Nov 2013 to Jun 2015v40
  6. Re-verified, no change to tracked fieldsv39
  7. Trial status: Recruiting to Active, Not Recruiting Site details revised at 10 of 10 sitesv38 Show all 2 changesShow less
    • Site details revised at 10 of 10 sites
  8. Primary completion date: May 2010 to Nov 2013 Enrollment target: 544 to 800 · Completion date: Nov 2013 · Study title shortened, about 9 wordsv37 Show all 4 changesShow less
    • Enrollment target: 544 to 800
    • Completion date: Nov 2013
    • Study title shortened, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  9. Re-verified, no change to tracked fieldsv36
  10. Publications: details revised at 1 of 4 entriesv35
  11. 2 versions Re-verified since May 9, 2009, no change to tracked fieldsv33-v34
  12. Interventions: asparaginase (Drug), cyclophosphamide (Drug), cytarabine (Drug), dexamethasone (Drug), dexrazoxane hydrochloride (Drug), doxorubicin… to asparaginase (Drug), cyclophosphamide (Drug), cytarabine (Drug), dexamethasone (Drug), dexrazoxane hydrochloride (Drug), doxorubicin…v32
  13. Study sites: 9 to 10v31
  14. Re-verified, no change to tracked fieldsv30
  15. Site contacts updated at 1 of 9 sitesv29
  16. 4 versions Re-verified since Aug 27, 2008, no change to tracked fieldsv25-v28
  17. Interventions: asparaginase (Drug), cyclophosphamide (Drug), cytarabine (Drug), dexamethasone (Drug), dexrazoxane hydrochloride (Drug), doxorubicin… to asparaginase (Drug), cyclophosphamide (Drug), cytarabine (Drug), dexamethasone (Drug), dexrazoxane hydrochloride (Drug), doxorubicin…v24
  18. 3 versions Re-verified since Jun 17, 2008, no change to tracked fieldsv21-v23
  19. Interventions: asparaginase (Drug), cyclophosphamide (Drug), cytarabine (Drug), dexamethasone (Drug), dexrazoxane hydrochloride (Drug), doxorubicin… to asparaginase (Drug), cyclophosphamide (Drug), cytarabine (Drug), dexamethasone (Drug), dexrazoxane hydrochloride (Drug), doxorubicin… Study arms: 0 to 2v20 Show all 2 changesShow less
    • Study arms: 0 to 2
  20. Interventions: asparaginase (Drug), cardiotoxicity attenuation (Procedure), chemotherapy (Procedure), cyclophosphamide (Drug), cytarabine (Drug)… to asparaginase (Drug), cyclophosphamide (Drug), cytarabine (Drug), dexamethasone (Drug), dexrazoxane hydrochloride (Drug), doxorubicin…v19
  21. Re-verified, no change to tracked fieldsv18
  22. Study sites revised (9)v17 Show moreShow less

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  23. Re-verified, no change to tracked fieldsv16
  24. Interventions: asparaginase (Drug), cardiotoxicity attenuation (Procedure), chemotherapy (Procedure), complications of therapy management (Procedure)… to asparaginase (Drug), cardiotoxicity attenuation (Procedure), chemotherapy (Procedure), cyclophosphamide (Drug), cytarabine (Drug)…v15
  25. Primary completion date: May 2010v14
  26. Site contacts updated at 1 of 9 sitesv13
  27. Interventions: asparaginase (Drug), cardiotoxicity attenuation (Procedure), chemoprotection (Procedure), chemotherapy (Procedure), complications of… to asparaginase (Drug), cardiotoxicity attenuation (Procedure), chemotherapy (Procedure), complications of therapy management (Procedure)…v12
  28. Study sites: 10 to 9v11
  29. Site contacts updated at 1 of 10 sitesv10
  30. Site contacts updated at 2 of 10 sitesv9
  31. Study sites revised (10)v8 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  32. Study sites: 9 to 10v7
  33. Interventions: asparaginase (Drug), cardiotoxicity attenuation (Procedure), chemoprotection (Procedure), chemotherapy (Procedure), complications of… to asparaginase (Drug), cardiotoxicity attenuation (Procedure), chemoprotection (Procedure), chemotherapy (Procedure), complications of…v6
  34. Study Status, Study Description, Eligibilityv5
  35. Re-verified, no change to tracked fieldsv4
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RATIONALE: L-asparaginase is an important component of treatment for childhood acute lymphoblastic leukemia, but is also associated with notable side-effects, including hypersensitivity, pancreatitis, and thrombosis. We have previously reported that patients with acute lymphoblastic leukemia in whom asparaginase treatment was discontinued because of intolerable side-effects had survival outcomes that were inferior to those who received all or nearly all of their intended doses. Two bacterial sources of asparaginase exist: Escherichia coli (E coli) and Erwinia chrysanthemia (Erwinia). Generally, the E coli-derived enzyme has been used as front-line therapy and the Erwinia-derived preparation has been reserved for patients who develop hypersensitivity reactions. Pegylated E coli asparaginase (PEG-asparaginase) has a longer half-life and is potentially less immunogenic than native E coli L-asparaginase, and has been used as the initial asparaginase preparation in some pediatric acute lymphoblastic leukemia treatment regimens. PURPOSE: Although the pharmacokinetics of each of these asparaginase preparations: intravenous PEG-asparaginase (IV-PEG) and intramuscular native E coli L-asparaginase (IM-EC) have been well characterized, their relative efficacy and toxicity have not been studied extensively.
Trial Details
NCT Number NCT00400946
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: National Cancer Institute (NCI)
Conditions Drug/Agent Toxicity by Tissue/Organ, Leukemia
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov