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A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion pushed from Jun 30, 2026 to Oct 30, 2026v14
  2. Re-verified, no change to tracked fieldsv13
  3. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2026v12
  4. Re-verified, no change to tracked fieldsv11
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 64 to confirmed 44 · Site details revisedv10 Show 2 more changesShow less
    • Enrollment target: estimated 64 to confirmed 44
    • Site details revised
Show 8 earlier versionsHide 8 earlier versions
  1. Interventions: Blinatumomab (Drug), Blinatumomab (Drug), Blinatumomab (Drug), Dexamethasone (Drug) to Blinatumomab (Drug), Blinatumomab 28 ug (Drug), Blinatumomab 9ug (Drug), Dexamethasone (Drug)v9
  2. Eligibility criteria revisedv8 See this version in full on ClinicalTrials.gov ↗
  3. Site contact updatedv7
  4. Phase: Phase 1 to Phase 1/2 Enrollment target: 12 to 64 · Primary and study completion dates: May 2020 to Jun 30, 2025 · Eligibility criteria expanded, about 28 wordsv6 Show 3 more changesShow less
    • Enrollment target: 12 to 64
    • Primary and study completion dates: May 2020 to Jun 30, 2025
    • Eligibility criteria expanded, about 28 words

    See this version in full on ClinicalTrials.gov ↗

  5. Phase: Early Phase 1 to Phase 1v5
  6. Collaborators expanded, about 1 wordv4 See this version in full on ClinicalTrials.gov ↗
  7. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 21, 2017 to Sep 5, 2017 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Aug 21, 2017 to Sep 5, 2017
    • Site details revised
  8. Start date: May 2017 to Aug 21, 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The investigators primary objective is to determine the safety and toxicity of incorporating blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance setting for patients with CD19+-B-cell malignancies (Acute Lymphoblastic Leukemia \[ALL\], Non-Hodgkin's Lymphoma \[NHL\]).
Trial Details
NCT Number NCT03114865
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Amgen
Conditions Acute Lymphoblastic Leukemia, B-cell Non Hodgkin Lymphoma, Pre B-Cell Acute Lymphoblastic Leukaemia
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov