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

NCT01666080 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-24

No results posted yet for this study

Summary

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.

Conditions

  • Hematologic Disorders
  • Hemoglobinopathies
  • Immunodeficiencies

Interventions

DRUG

Busulfan

0.4 mg/kg (0.5 mg/kg if \<4 years of age) intravenously (IV) every 6 hours on Days -8 and -7.

DRUG

Fludarabine

40 mg/m\^2 intravenously (IV) over 1 hour on days -6 through -2.

RADIATION

Total body irradiation

200 cGy on Day -1

BIOLOGICAL

Stem cell transplant

stem cell infusion on day 0

DRUG

Keppra

Keppra will be given for seizure prophylaxis during busulfan administration as per the standard institutional protocol.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Troy Lund, M.D., Ph.D. · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01666080 on ClinicalTrials.gov