Total Marrow and Lymphoid Irradiation Before Donor Transplant and Cyclophosphamide in Treating Patients With Acute Myeloid Leukemia

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later Sep 6, 2026 → Apr 12, 2027
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 6, 2026 to Apr 12, 2027 Show 4 more changesShow less
    • Trial status changed: Suspended → Active, Not Recruiting
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 9 of 18 entries
    • Study description revised
  2. Trial status: Recruiting to Suspended Sponsor's reason: accrual goal
    • Enrollment target: estimated 18 to confirmed 56
    • Primary and study completion dates: Apr 6, 2026 to Sep 6, 2026
    • Site details revised
    v18
  3. Primary and study completion dates: Dec 30, 2024 to Apr 6, 2026v17
  4. Primary and study completion dates: Dec 30, 2023 to Dec 30, 2024v16
  5. Primary completion date: Dec 30, 2022 to Dec 30, 2023
    • Study completion date: Jan 30, 2023 to Dec 30, 2023
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Dec 30, 2019 to Dec 30, 2022
    • Site details revised
    v14
  2. Study completion date: Jan 30, 2022 to Jan 30, 2023v13
  3. Primary completion date changed from estimate of Oct 21, 2021 to Dec 30, 2019
    • Study completion date: Oct 21, 2021 to Jan 30, 2022
    v12
  4. Primary and study completion dates: Oct 21, 2020 to Oct 21, 2021v11 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 24 to confirmed 18
    • Start date: Mar 6, 2018 to Mar 19, 2018
    • Study site revised
  5. Primary and study completion dates: Jun 2020 to Oct 21, 2020v10 Show 5 more changesShow less
    • Start date: Mar 19, 2018 to Mar 6, 2018
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints revised (18)
    • Study site revised
    • Study description expanded, about 3 words
  6. Re-verified, no change to tracked fieldsv9
  7. Study description revisedv8
  8. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints revised (18)
    v7
  9. Re-verified, no change to tracked fieldsv6
  10. Primary and study completion dates: Jun 1, 2020 to Jun 2020v5
  11. Eligibility criteria shortened, about 16 wordsv4
  12. Secondary endpoints: details revised at 2 of 18 entriesv3
  13. Start date changed from estimate of May 1, 2018 to Mar 19, 2018v2
  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.
This pilot phase I trial studies the side effects of total bone marrow and lymphoid irradiation and how well it works with cyclophosphamide in treating patients with acute myeloid leukemia. Total marrow and lymphoid irradiation targets cancer in bone marrow and blood, instead of applying radiation to the whole body. Giving total bone marrow and lymphoid irradiation before a donor transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, 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. Giving total bone marrow and lymphoid irradiation before donor transplant and cyclophosphamide after transplant may work better at treating acute myeloid leukemia.
Trial Details
NCT Number NCT03467386
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov