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Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 26% 475 → 352 participants
See other at-risk trials from Children's Oncology Group

Record History

The 50 most recent of 66 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Children's Oncology Group to Children's Oncology Group Completion pushed from Aug 14, 2027 to Sep 30, 2034 · Secondary endpoints: details revised at 4 of 11 entries · Study description revised · 3 more Show 6 more changesShow less
    • Completion pushed from Aug 14, 2027 to Sep 30, 2034
    • Secondary endpoints: details revised at 4 of 11 entries
    • Study description revised
    • Site details revised at 102 of 226 sites
    • Collaborators revised (2)
    • Eligibility criteria shortened, about 1 word
  2. Primary completion moved earlier from Sep 30, 2027 to Jun 30, 2026 Enrollment reduced: 475 → 352 participants · Completion moved earlier from Sep 30, 2027 to Aug 14, 2027 · Study sites revised (226)v65 Show 3 more changesShow less
    • Enrollment reduced: 475 → 352 participants
    • Completion moved earlier from Sep 30, 2027 to Aug 14, 2027
    • Study sites revised (226)

    See this version in full on ClinicalTrials.gov ↗

  3. Study description expanded, about 75 wordsv64 See this version in full on ClinicalTrials.gov ↗
  4. Study sites revised (226)v63 See this version in full on ClinicalTrials.gov ↗
  5. 2 versions Re-verified since Sep 17, 2025, no change to tracked fieldsv61-v62
Show 44 earlier versionsHide 44 earlier versions
  1. Study sites revised (226)v60 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 227 to 226v59
  3. Re-verified, no change to tracked fieldsv58
  4. Interventions: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Calaspargase Pegol (Drug), Cyclophosphamide (Drug), Cytarabine (Drug)… to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Calaspargase Pegol (Drug), Cyclophosphamide (Drug), Cytarabine (Drug)… Study description expanded, about 160 words · Study sites revised (227) · Eligibility criteria expanded, about 3 wordsv57 Show 3 more changesShow less
    • Study description expanded, about 160 words
    • Study sites revised (227)
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites revised (227)v56 See this version in full on ClinicalTrials.gov ↗
  6. Study sites revised (227)v55 See this version in full on ClinicalTrials.gov ↗
  7. Re-verified, no change to tracked fieldsv54
  8. Study sites: 213 to 227v53
  9. Trial status: Recruiting to Active, Not Recruiting Study sites: 227 to 213 · Collaborators revised (2)v52 Show 2 more changesShow less
    • Study sites: 227 to 213
    • Collaborators revised (2)

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites revised (227)v51 See this version in full on ClinicalTrials.gov ↗
  11. Re-verified, no change to tracked fieldsv50
  12. Site details revised at 8 of 227 sitesv49
  13. Study sites: 213 to 227v48
  14. Study sites: 227 to 213 Start date: Jul 28, 2017 to Aug 8, 2017 · Collaborators revised (2)v47 Show 2 more changesShow less
    • Start date: Jul 28, 2017 to Aug 8, 2017
    • Collaborators revised (2)

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 225 to 227v46
  16. Collaborators: 1 to 2v45 See this version in full on ClinicalTrials.gov ↗
  17. Study sites: 211 to 225v44
  18. Study sites: 212 to 211v43
  19. Study sites: 225 to 212v42
  20. Study sites: 224 to 225v41
  21. Site contacts updated at 4 of 224 sitesv40
  22. Secondary endpoints: details revised at 1 of 11 entries Site details revised at 9 of 224 sitesv39 Show 1 more changeShow less
    • Site details revised at 9 of 224 sites
  23. Study sites: 220 to 224 Interventions: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride… to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Calaspargase Pegol (Drug), Cyclophosphamide (Drug), Cytarabine (Drug)… · Eligibility criteria expanded, about 12 words · Study description expanded, about 9 wordsv38 Show 3 more changesShow less
    • Interventions: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride… to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Calaspargase Pegol (Drug), Cyclophosphamide (Drug), Cytarabine (Drug)…
    • Eligibility criteria expanded, about 12 words
    • Study description expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  24. Primary and study completion dates: Mar 31, 2027 to Sep 30, 2027v37
  25. Study sites revised (220)v36 See this version in full on ClinicalTrials.gov ↗
  26. Primary and study completion dates: Mar 31, 2028 to Mar 31, 2027v35
  27. Study sites: 219 to 220v34
  28. Site details revised at 20 of 219 sitesv33
  29. Enrollment target: 700 to 475 Completion date: Jun 30, 2028 to Mar 31, 2028 · Secondary endpoints: 7 to 11 · Study sites revised (219) · 1 morev32 Show 4 more changesShow less
    • Completion date: Jun 30, 2028 to Mar 31, 2028
    • Secondary endpoints: 7 to 11
    • Study sites revised (219)
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  30. Study sites revised (219)v31 See this version in full on ClinicalTrials.gov ↗
  31. Site details revised at 1 of 219 sitesv30
  32. Study sites: 215 to 219v29
  33. Study sites revised (215)v28 See this version in full on ClinicalTrials.gov ↗
  34. Study sites: 213 to 215v27
  35. Site details revised at 11 of 213 sitesv26
  36. Primary completion date: Jun 30, 2028 to Mar 31, 2028v25
  37. Study sites: 205 to 213v24
  38. Study sites: 204 to 205v23
  39. Study sites: 203 to 204v22
  40. Study sites: 189 to 203v21
  41. Study sites: 202 to 189v20
  42. Study sites: 188 to 202v19
  43. Study sites: 184 to 188v18
  44. Study sites: 183 to 184v17
  • 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 studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.
Trial Details
NCT Number NCT03007147
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI), Universita degli Studi di Milano-Bicocca
Conditions Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia, T Acute Lymphoblastic Leukemia
Enrollment 352 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov