Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT01666080
Status
Recruiting
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Conditions

  • Hematologic Disorders
  • Hemoglobinopathies
  • Immunodeficiencies

Eligibility Criteria

Sex
ALL
Age
N/A - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Busulfan — DRUG
    0.4 mg/kg (0.5 mg/kg if \<4 years of age) intravenously (IV) every 6 hours on Days -8 and -7.
  • Fludarabine — DRUG
    40 mg/m\^2 intravenously (IV) over 1 hour on days -6 through -2.
  • Total body irradiation — RADIATION
    200 cGy on Day -1
  • Stem cell transplant — BIOLOGICAL
    stem cell infusion on day 0
  • Keppra — DRUG
    Keppra will be given for seizure prophylaxis during busulfan administration as per the standard institutional protocol.

Study Details

This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with non-malignant or malignant diseases. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HCT.

Key Dates

Start date
Aug 31, 2012
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Reduced Intensity Conditioning
    Includes patients receiving a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using reduced intensity conditioning (RIC). Patients will receive busulfan, fludarabine, total body irradiation and stem cell transplant. Keppra will be given for seizure prophylaxis.

Primary Outcome Measure

Time to Engraftment [ Time Frame: Day 42 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455
Weston P. Miller, M.D.
[email protected]
612-626-2778
Weston P. Miller, M.D. (PRINCIPAL_INVESTIGATOR)

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