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Alkylating agents

Reduced Intensity Stem Cell Transplant for Blood Disorders

N/A
Recruiting
Led By Troy Lund, M.D., Ph.D.
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 0 to 55 years
Be younger than 65 years old
Must not have
Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI). Radiation Oncology will evaluate all patients who have had previous radiation therapy or TBI for approval to receive an additional 200 cGy of TBI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 1 year
Awards & highlights

Summary

This trialprovides a treatment guideline to help patients with non-malignant or malignant diseases who may have failed a previous stem cell transplant.

Who is the study for?
This trial is for individuals aged 0 to 55 needing a second or subsequent stem cell transplant due to inadequate donor chimerism after a previous transplant. It's open to those with matched donors, including siblings and unrelated cord blood units. Pregnant women, HIV-positive individuals, and those who can't safely receive additional radiation are excluded.
What is being tested?
The study tests a reduced intensity conditioning regimen using Busulfan, Fludarabine, and low-dose total body irradiation aimed at promoting engraftment in patients whose previous transplants didn't take sufficiently. Both bone marrow and peripheral blood grafts are considered.
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to new cells (like Graft vs Host Disease), medication-related issues such as nausea or seizures from Keppra, organ damage from chemotherapy drugs like Busulfan, and risks associated with radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 0 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had radiation therapy before and need approval for more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Engraftment
Secondary study objectives
Change in Incidence of Chronic Graft-Versus-Host Disease (GVHD)
Incidence of Acute Graft-Versus-Host Disease (GVHD)
Incidence of Graft Failure
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Reduced Intensity ConditioningExperimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total body irradiation
2008
Completed Phase 3
~1080
Levetiracetam
FDA approved
Busulfan
FDA approved
Stem cell transplant
2011
Completed Phase 3
~700
Fludarabine
FDA approved

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
279 Previous Clinical Trials
15,553 Total Patients Enrolled
Troy Lund, M.D., Ph.D.Principal InvestigatorMasonic Cancer Center, University of Minnesota

Media Library

Busulfan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01666080 — N/A
Hemoglobin Disorders Research Study Groups: Reduced Intensity Conditioning
Hemoglobin Disorders Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT01666080 — N/A
Busulfan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01666080 — N/A
~1 spots leftby Jun 2025