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GM-CSF With Post-Transplant Cyclophosphamide

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 18, 2026 → Dec 31, 2026
See other at-risk trials from Northside Hospital, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 18, 2026 to Dec 31, 2026
    • Study completion pushed from Sep 18, 2026 to Dec 31, 2027
    • Eligibility criteria expanded, about 7 words
  2. Re-verified, no change to tracked fieldsv14
  3. Primary and study completion dates: Sep 18, 2025 to Sep 18, 2026v13
  4. Re-verified, no change to tracked fieldsv12
  5. Primary completion date: Sep 18, 2024 to Sep 18, 2025v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: May 18, 2024 to Sep 18, 2024
    • Study completion date: May 18, 2025 to Sep 18, 2025
    v10
  2. 2 versions Re-verified since Oct 19, 2022, no change to tracked fieldsv8-v9
  3. Primary completion date: May 18, 2023 to May 18, 2024
    • Study completion date: May 18, 2024 to May 18, 2025
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Primary completion date: May 18, 2022 to May 18, 2023
    • Study completion date: May 18, 2023 to May 18, 2024
    v5
  6. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: May 15, 2022 to May 18, 2022
    • Study completion date: May 15, 2023 to May 18, 2023
    • Start date changed from estimate of May 15, 2020 to May 18, 2020
    • Site details revised
  7. Start date: Mar 15, 2020 to May 15, 2020
    • Primary completion date: Mar 15, 2022 to May 15, 2022
    • Study completion date: Mar 15, 2022 to May 15, 2023
    v3
  8. Interventions: Sargramostim (Drug) to Control Arm (Other), Sargramostim (Drug)v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Given the increased number of HLA-mismatched haploidentical transplantation with post-transplant cyclophosphamide performed each year and the high risk of infectious complications associated with this type of transplant, the investigators suggest that GM-CSF administration post-infusion of T-replete haploidentical stem cells and post-transplant cyclophosphamide can yield similar count recovery rates to G-CSF with a potential of lowering risk of infectious complications.
Trial Details
NCT Number NCT04237623
Lead Sponsor Northside Hospital, Inc.
Conditions
(from sponsor)		 Transplant-Related Hematologic Malignancy
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov