Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma

StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

The 50 most recent of 491 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Sep 16, 2026 to Sep 16, 2027 Show 4 more changesShow less
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description shortened, about 28 words
    • Study sites revised (212)
  2. Re-verified, no change to tracked fieldsv490
  3. Study sites revised (212)v489
  4. Re-verified, no change to tracked fieldsv488
  5. Study sites revised (212)v487
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (212)v486
  2. Re-verified, no change to tracked fieldsv485
  3. Study sites revised (212)v484
  4. Re-verified, no change to tracked fieldsv483
  5. Study completion date: Sep 18, 2025 to Sep 16, 2026v482
  6. Re-verified, no change to tracked fieldsv481
  7. Study sites revised (212)v480
  8. Study sites revised (212)v479
  9. 2 versions Re-verified since Feb 26, 2025, no change to tracked fieldsv477-v478
  10. Study sites revised (212)v476
  11. Re-verified, no change to tracked fieldsv475
  12. Study completion date: Sep 22, 2024 to Sep 18, 2025
    • Study sites revised (212)
    v474
  13. Study sites revised (212)v473
  14. Study sites revised (212)v472
  15. Study sites revised (212)v471
  16. 2 versions Re-verified since Nov 7, 2023, no change to tracked fieldsv469-v470
  17. Study completion date: Sep 22, 2023 to Sep 22, 2024
    • Start date: Sep 30, 2014 to Oct 4, 2014
    • Site details revised at 1 of 212 sites
    v468
  18. 2 versions Re-verified since May 2, 2023, no change to tracked fieldsv466-v467
  19. Study completion date: Dec 31, 2027 to Sep 22, 2023
    • Study description revised
    • Study sites revised (212)
    v465
  20. Results first posted: Feb 23, 2022v464 Show 4 more changesShow less
    • Enrollment target: 844 to 847
    • Study completion date: Dec 31, 2027
    • Secondary endpoints revised (5)
    • Primary endpoint revised
  21. Study Status, Study Description, Outcome Measures, Eligibilityv463
  22. Re-verified, no change to tracked fieldsv462
  23. Study sites revised (212)v461
  24. 4 versions Re-verified since Sep 15, 2020, no change to tracked fieldsv457-v460
  25. Study sites revised (212)v456
  26. Study sites revised (212)v455
  27. Study sites revised (212)v454
  28. 3 versions Re-verified since Apr 14, 2020, no change to tracked fieldsv451-v453
  29. Enrollment target: estimated 1400 to confirmed 844
    • Study sites revised (212)
    v450
  30. 7 versions Re-verified since Nov 18, 2019, no change to tracked fieldsv443-v449
  31. Study Status, Contacts/Locationsv442
  • 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 compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Trial Details
NCT Number NCT02112916
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Adult T Acute Lymphoblastic Leukemia, Ann Arbor Stage II Adult Lymphoblastic Lymphoma, Ann Arbor Stage II Childhood Lymphoblastic Lymphoma, Ann Arbor Stage III Adult Lymphoblastic Lymphoma, Ann Arbor Stage III Childhood Lymphoblastic Lymphoma, Ann Arbor Stage IV Adult Lymphoblastic Lymphoma, Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma, Childhood T Acute Lymphoblastic Leukemia
Related terms Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 847 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov