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Second Allogeneic Stem Cell Transplant for Hematologic Disorders

This study is for patients who need a second or more allogeneic hematopoietic stem cell transplant (HSCT), also known as a bone marrow transplant, because their first transplant didn't lead to enough donor cells growing in their body. It uses a reduced intensity conditioning (RIC) regimen, which means lower doses of chemotherapy and radiation. The treatment involves the drugs Busulfan and Fludarabine, along with low-dose total body irradiation (TBI), followed by the stem cell transplant. Keppra will also be given to prevent seizures during Busulfan administration. The main goal is to see how long it takes for the new stem cells to engraft (start growing and making new blood cells), which is measured at 42 days. This study is open to individuals up to 55 years old with certain blood disorders, hemoglobin problems, or immune system deficiencies. There are 30 planned participants, but the current recruitment status is unclear.

Study design
This is an interventional study with 30 planned participants. It is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant.
What's involved
You would receive Busulfan, Fludarabine, and Total Body Irradiation before a stem cell infusion. Routine clinical data will be collected and maintained in databases.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, time to engraftment, is measured at Day 42 after the transplant.

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NCT01666080

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

Recruiting
NAUp to 55InterventionalTreatment
Masonic Cancer Center, University of Minnesota
~30 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:BusulfanFludarabineTotal body irradiationStem cell transplantKeppra

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to Engraftment
Measured over Day 42

Conditions

Hematologic Disorders
Hemoglobinopathies
Immunodeficiencies

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Hematopoietic and Lymphoid Cell DisorderHemoglobinopathyImmunodeficiencyInherited Metabolic Disorders

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

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

Who to contact

Troy Lund, M.D., Ph.D.
[email protected]
612-625-2508
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Eligibility criteria

Inclusion

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
Transplantation using sufficiently matched related donors (such as matched siblings) or unrelated donors will be considered. Both granulocyte-colony stimulating factor (GCSF) stimulated peripheral blood grafts and bone marrow grafts will be considered, although bone marrow will be the priority.
Cord blood grafts, both related and unrelated, are also eligible. As this protocol will use a reduced intensity regimen, this protocol will use the current recommendations of the University of Minnesota for choosing cord blood grafts. If a single cord blood unit cell dose is insufficient, double cord transplantation should be considered if sufficiently matched cord blood units are available. The priority of choosing cord blood donors is based on the current institutional recommendations.
Exclusion of Metabolic Disorder or other Inherited Disorder Carrier Status from related donor and unrelated cord blood grafts as appropriate for primary disease.
Age, Performance Status, Consent
Age: 0 to 55 years
Consent: voluntary written consent (adult or parental/guardian)

Exclusion

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
Pregnant or breastfeeding
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
While it would be advantageous to begin therapy on this second transplant regimen \> 6 months following a prior myeloablative regimen or \>2 months after a reduced intensity regimen, it is recognized that there are circumstances where this may not be practical.

What this trial measures

  • Time to EngraftmentDay 42

    Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater.