Standard-of-Care Reduced-Intensity Conditioning (RIC) With 200 Versus 400 cGy of Total Body Irradiation (TBI) in Patients With Acute Leukemia Undergoing First Allogeneic Blood or Marrow Transplantation (BMT)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06803745
Status
Recruiting
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Conditions

  • Acute Leukemia
  • Acute Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 200 cGy or 400 cGy total body irradiation (TBI) — RADIATION
    Either 200 or 400cGy will be given as part of reduced-intensity conditioning prior to consolidative allogeneic bone marrow transplant (alloBMT)

Study Details

This is a randomized phase II trial of standard-of-care reduced-intensity conditioning (RIC) with 200 versus 400 cGy of total body irradiation (TBI) in patients with acute leukemia undergoing first allogeneic blood or marrow Transplantation (BMT). The primary objective is to compare the rates of graft-versus-host disease-free and relapse-free survival (GRFS) between patients in the two cohorts.

Key Dates

Start date
Mar 27, 2025
Status verified
Apr 2026
Primary completion
Mar 31, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: TBI: 200 Centigray (cGy)
    200 cGy TBI is administered based on randomization in a single fraction on Day -3, -2, or -1, depending on if and how many days of rest are permitted. A day of rest occurring after preparative regimen completion and prior to stem cell infusion, is not routinely scheduled. Up to two days of rest may be added in this window based on logistical considerations or clinically as indicated. For one day of rest, TBI would be administered on Day -2. For two days of rest, TBI would be administered on Day -3.
  • Active Comparator: TBI: 400 cGy
    400 cGy TBI is administered based on randomization in a single fraction on Day -3, -2, or -1, depending on if and how many days of rest are permitted. A day of rest occurring after preparative regimen completion and prior to stem cell infusion, is not routinely scheduled. Up to two days of rest may be added in this window based on logistical considerations or clinically as indicated. For one day of rest, TBI would be administered on Day -2. For two days of rest, TBI would be administered on Day -3.

Primary Outcome Measure

graft-versus-host disease-free, relapse-free survival (GRFS) [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287
Jonathan Webster, MD
[email protected]
410-614-9106

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By research site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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