Recruiting

Second or Greater Allogeneic Hematopoietic Stem Cell Transplant with Reduced Intensity Conditioning for Treatment

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Study Aim

This study aims to treat individuals undergoing their second or greater allogeneic hematopoietic stem cell transplant, using reduced intensity conditioning, with the primary goal of measuring the time it takes for neutrophil engraftment to occur.

What is being tested

Busulfan

+ Fludarabine

+ Total body irradiation

DrugRadiationBiological
Who is being recruted

Hemic and Lymphatic Diseases+4

+ Immune System Diseases

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Until 55 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorMasonic Cancer Center, University of Minnesota
Study ContactTroy Lund, M.D., Ph.D.More contacts
Last updated: July 6, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

There is no research element except the collection of routine clinical data. Patients will consent to allow routine clinical data to be collected and maintained in OnCore, the Masonic Cancer Center's (MCC) clinical database, and specific transplant related endpoints in the University Of Minnesota Blood and Bone Marrow Database as part of the historical database maintained by the department.

NCT01666080
Principal SponsorMasonic Cancer Center, University of Minnesota
Study ContactTroy Lund, M.D., Ph.D.More contacts
Last updated: July 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornHematologic DiseasesHemoglobinopathiesImmunologic Deficiency Syndromes

Criteria

5 inclusion criteria required to participate
Age: 0 to 55 years
Consent: voluntary written consent (adult or parental/guardian)
Diagnosis of any disease for which a second or greater hematopoietic stem cell transplant is needed due to insufficient donor chimerism following hematopoietic recovery after previous HSCT. Determination of "insufficiency of donor chimerism" will be made by the treating transplant physician. Occasionally donor derived engraftment may be present, but sustained aplasia or failed recovery of sufficient hematopoiesis requires administration of a second graft. This intervention may be used for both situations
Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program
Show More Criteria
4 exclusion criteria prevent from participating
Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted
HIV positive
Pregnant or breastfeeding
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Masonic Cancer Center, University of Minnesota

Minneapolis, United StatesOpen Masonic Cancer Center, University of Minnesota in Google Maps
Recruiting
One Study Center