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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 0 and 55 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Engraftment
Secondary outcome measures
Change in Incidence of Chronic Graft-Versus-Host Disease (GVHD)
Incidence of Acute Graft-Versus-Host Disease (GVHD)
Incidence of Graft Failure
+3 moreTrial 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
Busulfan
FDA approved
Fludarabine
FDA approved
Stem cell transplant
2011
Completed Phase 3
~700
Levetiracetam
FDA approved
Total body irradiation
2008
Completed Phase 3
~1080
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
272 Previous Clinical Trials
14,623 Total Patients Enrolled
Troy Lund, M.D., Ph.D.Principal InvestigatorMasonic Cancer Center, University of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 0 and 55 years old.I have a suitable donor for a transplant according to the University of Minnesota's criteria.I need a second stem cell transplant because the first one didn't work well.I am eligible for a transplant with a matched donor, preferring bone marrow over blood grafts.I am considering a second transplant less than 6 months after my first intense treatment or 2 months after a milder one.My doctor may use a previous donor's tissue for my transplant if possible.I have had radiation therapy before and need approval for more.My infection is under control or getting better with treatment.I am eligible for a cord blood transplant following the University of Minnesota's guidelines.My donor for the transplant does not carry any metabolic or inherited disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Reduced Intensity Conditioning
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other documented cases of this treatment being administered?
"There are currently 441 active medical studies using this treatment. Out of those, 32 have progressed to Phase 3 trials. Most of the research is based in Brisbane, Queensland; however, there are 4566 different research locations for this treatment."
Answered by AI
Are there any participants still needed for this research?
"This clinical trial, as indicated on clinicaltrials.gov, is actively seeking patients. The trial was originally posted on 8/1/2012 and was last edited on 11/2/2022."
Answered by AI
What is the primary condition that this medication is designed to address?
"This treatment can be used to help those who have failed to respond to conventional therapy, have undergone an allogeneic hematopoietic stem cell transplant, or suffer from idiopathic generalized epilepsy."
Answered by AI
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