Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 10 months later Jun 23, 2026 → May 11, 2027
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Record History

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  1. Minor Start date moved earlier from Feb 7, 2020 to Feb 6, 2020
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 4 of 11 entries
    • Study description revised
  2. Notable Primary and study completion pushed from Jun 23, 2026 to May 11, 2027v11
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 70 to confirmed 33
    • Primary and study completion dates: Jan 4, 2026 to Jun 23, 2026
    • Site details revised
    v10
  4. Minor Primary and study completion dates: Aug 4, 2025 to Jan 4, 2026v9
  5. Re-verified, no change to tracked fieldsv8
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  1. Notable Primary and study completion dates: Feb 4, 2024 to Aug 4, 2025v7
  2. 4 versions Re-verified since Sep 3, 2020, no change to tracked fieldsv3-v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2020 to Feb 7, 2020
    • Site details revised
    v2
  1. Study First Submitted
  • 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 II trial studies how well total marrow and lymphoid irradiation works as a conditioning regimen before hematopoietic cell transplantation in patients with myelodysplastic syndrome or acute leukemia. Total body irradiation can lower the relapse rate but has some fatal side effects such as irreversible damage to normal internal organs and graft-versus-host disease (a complication after transplantation in which donor's immune cells recognize the host as foreign and attack the recipient's tissues). Total body irradiation is a form of radiotherapy that involves irradiating the patient's entire body in an attempt to suppress the immune system, prevent rejection of the transplanted bone marrow and/or stem cells and to wipe out any remaining cancer cells. Intensity-modulated radiation therapy (IMRT) is a more recently developed method of delivering radiation. Total marrow and lymphoid irradiation is a method of using IMRT to direct radiation to the bone marrow. Total marrow and lymphoid irradiation may allow a greater dose of radiation to be delivered to the bone marrow as a preparative regimen before hematopoietic cell transplant while causing less side effects to normal organs than standard total body irradiation.
Trial Details
NCT Number NCT04262843
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, Myelodysplastic Syndrome
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov