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Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 58 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (231)v58 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 230 to 231v57
  3. Eligibility criteria expanded, about 75 words Study sites revised (230)v56 Show 1 more changeShow less
    • Study sites revised (230)

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv55
  5. Study sites revised (230)v54 See this version in full on ClinicalTrials.gov ↗
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 9 of 230 sitesv53
  2. Site details revised at 12 of 230 sites Study description shortened, about 4 wordsv52 Show 1 more changeShow less
    • Study description shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 21 of 230 sitesv51
  4. Primary and study completion dates: Mar 31, 2030 to Mar 31, 2032 Primary endpoint revised · Enrollment target: 4997 to 5951 · Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Bone Scan (Procedure), Calaspargase… to Biospecimen Collection (Procedure), Blinatumomab (Biological), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Bone… · 5 morev50 Show 8 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 4997 to 5951
    • Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Bone Scan (Procedure), Calaspargase… to Biospecimen Collection (Procedure), Blinatumomab (Biological), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Bone…
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 5 to 6
    • Study description shortened, about 15 words
    • Site details revised at 6 of 230 sites
    • Study arms: 5 to 4

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites revised (230)v49 See this version in full on ClinicalTrials.gov ↗
  6. Site details revised at 6 of 230 sitesv48
  7. Site details revised at 4 of 230 sitesv47
  8. Study sites revised (230)v46 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 229 to 230v45
  10. Site details revised at 4 of 229 sitesv44
  11. Site details revised at 12 of 229 sitesv43
  12. Study sites: 228 to 229v42
  13. Study sites revised (228)v41 See this version in full on ClinicalTrials.gov ↗
  14. Site details revised at 4 of 228 sitesv40
  15. Study sites revised (228)v39 See this version in full on ClinicalTrials.gov ↗
  16. Site details revised at 4 of 228 sitesv38
  17. Site details revised at 2 of 228 sitesv37
  18. Study sites: 227 to 228v36
  19. Study sites: 226 to 227v35
  20. Primary and study completion dates: Jun 30, 2029 to Mar 31, 2030 Primary endpoint revised · Enrollment target: 4772 to 4997 · Study description expanded, about 7 words · 2 morev34 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 4772 to 4997
    • Study description expanded, about 7 words
    • Site details revised at 194 of 226 sites
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  21. Site details revised at 10 of 226 sitesv33
  22. Primary endpoint revised Start date: Oct 28, 2019 to Oct 31, 2019 · Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Bone Scan (Procedure), Calaspargase… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Bone Scan (Procedure), Calaspargase… · Eligibility criteria expanded, about 128 words · 3 morev32 Show 6 more changesShow less
    • Start date: Oct 28, 2019 to Oct 31, 2019
    • Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Bone Scan (Procedure), Calaspargase… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Bone Scan (Procedure), Calaspargase…
    • Eligibility criteria expanded, about 128 words
    • Secondary endpoints revised (5)
    • Study description shortened, about 62 words
    • Study sites revised (226)

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 225 to 226v31
  24. Study sites: 224 to 225v30
  25. Study sites: 223 to 224v29
  26. Study sites: 222 to 223v28
  27. Site details revised at 5 of 222 sitesv27
  28. Study sites: 218 to 222 Interventions: Calaspargase Pegol-mknl (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug), Dexamethasone (Drug)… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Bone Scan (Procedure), Calaspargase… · Eligibility criteria expanded, about 12 words · Secondary endpoints: 4 to 5 · 1 morev26 Show 4 more changesShow less
    • Interventions: Calaspargase Pegol-mknl (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug), Dexamethasone (Drug)… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Bone Scan (Procedure), Calaspargase…
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  29. Re-verified, no change to tracked fieldsv25
  30. Site details revised at 8 of 218 sitesv24
  31. Site details revised at 14 of 218 sitesv23
  32. Site details revised at 2 of 218 sitesv22
  33. Study sites: 217 to 218v21
  34. Enrollment target: 3698 to 4772 Study sites: 216 to 217 · Study description expanded, about 21 wordsv20 Show 2 more changesShow less
    • Study sites: 216 to 217
    • Study description expanded, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  35. Site details revised at 6 of 216 sitesv19
  36. Study sites: 213 to 216v18
  37. Primary and study completion dates: May 31, 2027 to Jun 30, 2029v17
  38. Site details revised at 5 of 213 sitesv16
  39. Site details revised at 5 of 213 sitesv15
  40. Site details revised at 3 of 213 sitesv14
  41. Interventions: Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug), Dexamethasone (Drug), Doxorubicin Hydrochloride (Drug)… to Calaspargase Pegol-mknl (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug), Dexamethasone (Drug)… Study description expanded, about 197 words · Site details revised at 8 of 213 sitesv13 Show 2 more changesShow less
    • Study description expanded, about 197 words
    • Site details revised at 8 of 213 sites

    See this version in full on ClinicalTrials.gov ↗

  42. Study sites: 212 to 213v12
  43. Study sites: 211 to 212v11
  44. Study sites: 209 to 211v10
  45. Study sites: 198 to 209 Interventions: Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin (Drug), Daunorubicin Hydrochloride (Drug), Dexamethasone (Drug), Doxorubicin… to Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug), Dexamethasone (Drug), Doxorubicin Hydrochloride (Drug)… · Eligibility criteria expanded, about 31 words · Study description expanded, about 72 wordsv9 Show 3 more changesShow less
    • Interventions: Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin (Drug), Daunorubicin Hydrochloride (Drug), Dexamethasone (Drug), Doxorubicin… to Cyclophosphamide (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug), Dexamethasone (Drug), Doxorubicin Hydrochloride (Drug)…
    • Eligibility criteria expanded, about 31 words
    • Study description expanded, about 72 words

    See this version in full on ClinicalTrials.gov ↗

  • 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 phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.
Trial Details
NCT Number NCT03959085
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
Enrollment 5,951 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov