Status:
COMPLETED
Stem Cell Transplant for Immunologic or Histiocytic Disorders
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Hemophagocytic Lymphohistiocytosis
X-Linked Lymphoproliferative Disorders
Eligibility:
All Genders
Up to 35 years
Phase:
PHASE2
Brief Summary
This study tests the clinical outcomes of a preparative regimen of fludarabine (FLU), anti-thymocyte globulin (ATG)/or Campath, and melphalan; followed by hematopoietic stem cell transplant, and a pos...
Detailed Description
Prior to transplantation, subjects will receive Melphalan, Fludarabine and Anti-Thymocyte Globulin (ATG) or Campath. These three drugs are being given to subjects to help the new stem cells take and g...
Eligibility Criteria
Inclusion
- Patients with immunodeficiencies or histiocytic disorders 0-35 years of age with an acceptable stem cell donor and disease characteristic defined by the following:
- Patients with histocytic disorders (hemophagocytic lymphohistiocytosis of any etiology and refractory Langerhans cell histiocytosis) who do not meet eligibility criteria for a myeloablative transplant procedure
- Patients with immunodeficiency disorders in whom residual immune function may not require a fully myeloablative preparative regimen or patient is ineligible for standard myeloablative preparative regimen (any form of severe combined immunodeficiency \[SCID\], or other immunodeficiency with T cell defect)
- Patients with immunodeficiency disorders that have had poor outcome with myeloablative stem cell transplants (including, but not limited to, common variable immunodeficiency \[CVID\], Wiskott Aldrich Syndrome \[WAS\] if \> 5 years of age, ataxia telangiectasia)
- Patients with immunodeficiencies or histocytic disorders that require a second stem cell transplant (SCT) for any reason
Exclusion
- Karnofsky or Lansky performance score \<70
- Glomerular filtration rate (GFR)\<30% predicted
- Cardiac function \<50% normal by echocardiogram
- Serum creatinine \> 2x normal for age/weight
- Pregnant or lactating females
- Active serious infection that has not had an adequate course of therapy pre-SCT. Any patient with acquired immune deficiency syndrome (AIDS) or AIDS-related complex (ARC) or human immunodeficiency virus (HIV) seropositivity
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00176865
Start Date
August 1 2002
End Date
August 1 2014
Last Update
December 28 2017
Active Locations (1)
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1
Masonic Cancer Center University of Minnesota
Minneapolis, Minnesota, United States, 55455