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



Status:Recruiting
Conditions:Infectious Disease, HIV / AIDS, Endocrine, Hematology
Therapuetic Areas:Endocrinology, Hematology, Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 55
Updated:9/28/2018
Start Date:August 2012
End Date:June 2019
Contact:Troy Lund, M.D., Ph.D.
Email:mill4991@umn.edu
Phone:612-625-2508

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This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell
transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with non-malignant
or malignant diseases. This regimen, consisting of busulfan, fludarabine, and low dose total
body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve
an acceptable level of donor-derived engraftment following a previous allogeneic HCT.

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.

Inclusion Criteria:

- 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.

At the discretion of the treating transplant physician, an allograft from the previous
donor may be used, if available.

- Age, Performance Status, Consent

- Age: 0 to 55 years

- Consent: voluntary written consent (adult or parental/guardian)

Exclusion Criteria:

- 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.
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Principal Investigator: Weston P. Miller, M.D.
Phone: 612-626-2778
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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mi
from
Minneapolis, MN
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