Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

The 50 most recent of 533 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 shortened, about 44 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Study sites revised (186)
  2. 2 versions Re-verified since Jun 2, 2026, no change to tracked fieldsv531-v532
  3. Study sites revised (186)v530
  4. Study sites revised (186)v529
  5. Re-verified, no change to tracked fieldsv528
Show 44 earlier versionsHide 44 earlier versions
  1. Study sites revised (186)v527
  2. Study completion date: Sep 18, 2025 to Sep 16, 2026v526
  3. Re-verified, no change to tracked fieldsv525
  4. Study sites revised (186)v524
  5. Study sites revised (186)v523
  6. 2 versions Re-verified since Feb 26, 2025, no change to tracked fieldsv521-v522
  7. Study sites revised (186)v520
  8. Re-verified, no change to tracked fieldsv519
  9. Study completion date: Sep 22, 2024 to Sep 18, 2025
    • Study sites revised (186)
    v518
  10. Re-verified, no change to tracked fieldsv517
  11. Study sites revised (186)v516
  12. Study sites revised (186)v515
  13. 2 versions Re-verified since Nov 7, 2023, no change to tracked fieldsv513-v514
  14. Study sites revised (186)v512
  15. Study completion date: Apr 30, 2024 to Sep 22, 2024
    • Start date: Dec 8, 2014 to Dec 17, 2014
    • Site details revised at 1 of 186 sites
    v511
  16. Re-verified, no change to tracked fieldsv510
  17. Study completion date: Jun 23, 2023 to Apr 30, 2024v509
  18. 3 versions Re-verified since Jan 27, 2023, no change to tracked fieldsv506-v508
  19. Study completion date: Dec 31, 2030 to Jun 23, 2023
    • Interventions: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Asparaginase (Drug), Blinatumomab (Biological), Cyclophosphamide (Drug)… to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Asparaginase (Drug), Blinatumomab (Biological), Cyclophosphamide (Drug)…
    • Study sites revised (186)
    v505
  20. Results first posted: Dec 6, 2022
    • Enrollment target: 670 to 669
    • Secondary endpoints revised (2)
    • Study description expanded, about 1 word
    v504
  21. Secondary endpoints: details revised at 2 of 2 entriesv503
  22. Secondary endpoints: details revised at 2 of 2 entriesv502
  23. Study completion date: Jun 30, 2022 to Dec 31, 2030v501
  24. Study Status, Study Description, Outcome Measuresv500
  25. 5 versions Re-verified since Jul 30, 2021, no change to tracked fieldsv495-v499
  26. Enrollment target: estimated 598 to confirmed 670
    • Primary completion date changed from estimate of Dec 31, 2022 to Jun 30, 2021
    • Study completion date: Jun 30, 2022
    v494
  27. Re-verified, no change to tracked fieldsv493
  28. Study sites revised (186)v492
  29. 3 versions Re-verified since Jan 12, 2021, no change to tracked fieldsv489-v491
  30. Study sites revised (186)v488
  31. 3 versions Re-verified since Sep 15, 2020, no change to tracked fieldsv485-v487
  32. Study Status, Contacts/Locationsv484
  • 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 studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.
Trial Details
NCT Number NCT02101853
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Recurrent B Acute Lymphoblastic Leukemia
Related terms Burkitt Lymphoma
Enrollment 669 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov