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

  • STATUS
    Recruiting
  • End date
    Jun 24, 2022
  • participants needed
    30
  • sponsor
    Masonic Cancer Center, University of Minnesota
Updated on 24 January 2021
stem cell transplantation
total body irradiation
fludarabine
busulfan
granulocyte colony stimulating factor
myeloablative conditioning
reduced intensity conditioning
g-csf
allogeneic hematopoietic stem cell transplant

Summary

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.

Description

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.

Details
Condition Immunodeficiency, Blood disorder, Hemoglobinopathy, Immune Deficiency, Primary Immunodeficiency Disorders, Hematological Disorders, hemoglobinopathies, hematologic disorder, blood disorders, hematologic disorders, hematologic disease, blood diseases, hematological disease, blood dyscrasias, blood dyscrasia, haematological disorders, immunodeficient, immunodeficiencies, decreased immune function
Treatment busulfan, Fludarabine, Total body irradiation, Stem Cell Transplant, Keppra
Clinical Study IdentifierNCT01666080
SponsorMasonic Cancer Center, University of Minnesota
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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