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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 668 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv668
  2. Trial status: Active, Not Recruiting to Completed Study completion date changed from estimate of Mar 7, 2025 to Mar 31, 2025 · Start date: Jan 22, 2007 to Jan 30, 2007v667 Show 2 more changesShow less
    • Study completion date changed from estimate of Mar 7, 2025 to Mar 31, 2025
    • Start date: Jan 22, 2007 to Jan 30, 2007
  3. Study sites revised (215)v666 See this version in full on ClinicalTrials.gov ↗
  4. 2 versions Re-verified since Dec 3, 2024, no change to tracked fieldsv664-v665
  5. Study sites revised (215)v663 See this version in full on ClinicalTrials.gov ↗
Show 44 earlier versionsHide 44 earlier versions
  1. Study sites revised (215)v662 See this version in full on ClinicalTrials.gov ↗
  2. Study sites revised (215)v661 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (215)v660 See this version in full on ClinicalTrials.gov ↗
  4. Re-verified, no change to tracked fieldsv659
  5. Study sites revised (215)v658 See this version in full on ClinicalTrials.gov ↗
  6. Completion date: Mar 7, 2025v657
  7. Re-verified, no change to tracked fieldsv656
  8. Study sites revised (215)v655 See this version in full on ClinicalTrials.gov ↗
  9. 2 versions Re-verified since Nov 7, 2023, no change to tracked fieldsv653-v654
  10. Site details revised at 1 of 215 sitesv652
  11. 3 versions Re-verified since Mar 7, 2023, no change to tracked fieldsv649-v651
  12. Study sites revised (215)v648 See this version in full on ClinicalTrials.gov ↗
  13. Re-verified, no change to tracked fieldsv647
  14. Study sites revised (215)v646 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 216 to 215v645
  16. Study sites: 215 to 216v644
  17. Re-verified, no change to tracked fieldsv643
  18. Study sites revised (215)v642 See this version in full on ClinicalTrials.gov ↗
  19. 3 versions Re-verified since May 4, 2021, no change to tracked fieldsv639-v641
  20. Study sites revised (215)v638 See this version in full on ClinicalTrials.gov ↗
  21. 5 versions Re-verified since Feb 2, 2021, no change to tracked fieldsv633-v637
  22. Study sites revised (215)v632 See this version in full on ClinicalTrials.gov ↗
  23. 2 versions Re-verified since Oct 13, 2020, no change to tracked fieldsv630-v631
  24. Study sites revised (215)v629 See this version in full on ClinicalTrials.gov ↗
  25. Study sites revised (215)v628 See this version in full on ClinicalTrials.gov ↗
  26. 2 versions Re-verified since Apr 14, 2020, no change to tracked fieldsv626-v627
  27. Study sites revised (215)v625 See this version in full on ClinicalTrials.gov ↗
  28. Trial status: Completed to Active, Not Recruiting Completion date: Dec 31, 2017 to not stated · Study sites revised (215)v624 Show 2 more changesShow less
    • Completion date: Dec 31, 2017 to not stated
    • Study sites revised (215)

    See this version in full on ClinicalTrials.gov ↗

  29. Results first posted: Jun 20, 2019 Primary endpoints: 3 to 5 · Completion date: Sep 30, 2017 to Dec 31, 2017 · Secondary endpoint revisedv623 Show 3 more changesShow less
    • Primary endpoints: 3 to 5
    • Completion date: Sep 30, 2017 to Dec 31, 2017
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  30. Trial status: Active, Not Recruiting to Completed Completion date: Sep 30, 2017v622 Show 1 more changeShow less
    • Completion date: Sep 30, 2017
  31. Re-verified, no change to tracked fieldsv621
  32. Primary endpoints: 6 to 3 Secondary endpoints: 2 to 1 · Study description expanded, about 24 words · Study sites revised (215) · 1 morev620 Show 4 more changesShow less
    • Secondary endpoints: 2 to 1
    • Study description expanded, about 24 words
    • Study sites revised (215)
    • Study arms: 16 to 17

    See this version in full on ClinicalTrials.gov ↗

  33. Re-verified, no change to tracked fieldsv619
  • 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.
This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.
Trial Details
NCT Number NCT00408005
Lead Sponsor National Cancer Institute (NCI)
Conditions T Acute Lymphoblastic Leukemia, T Lymphoblastic Lymphoma
Enrollment 1,895 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov