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Total-Body Irradiation Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Severe Combined Immunodeficiency Undergoing Donor Bone Marrow Transplant

NCT00008450 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-07-29

No results posted yet for this study

Summary

This pilot clinical trial studies total-body irradiation followed by cyclosporine and mycophenolate mofetil in treating patients with severe combined immunodeficiency (SCID) undergoing donor bone marrow transplant. Giving total-body irradiation (TBI) before a donor bone marrow transplant using stem cells that closely match the patient's stem cells, helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may mix with the patient's immune cells and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

Conditions

  • Adenosine Deaminase Deficiency
  • Autosomal Recessive Disorder
  • Immune System Disorder
  • Purine-Nucleoside Phosphorylase Deficiency
  • Severe Combined Immunodeficiency
  • Severe Combined Immunodeficiency With Absence of T and B Cells
  • X-Linked Severe Combined Immunodeficiency

Interventions

PROCEDURE

Allogeneic Bone Marrow Transplantation

Undergo allogeneic bone marrow transplant

DRUG

Cyclosporine

Given PO or IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mycophenolate Mofetil

Given PO or IV

PROCEDURE

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Undergo nonmyeloablative allogeneic hematopoietic stem cell transplant

RADIATION

Total-Body Irradiation

Undergo TBI

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Lauri Burroughs · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-08-11
Primary Completion
2011-10-25
Completion
2018-12-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00008450 on ClinicalTrials.gov