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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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 1 year

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

Awards & Highlights

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.

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