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Stem Cell Transplant for Immunologic or Histiocytic Disorders

NCT00176865 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-12-28

Study results available
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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 post transplant regimen of Cyclosporin A (CsA) in patients with immunologic or histiocytic disorders. The researchers hypothesize that this regimen will have a positive effect on post transplant engraftment and the incidence of graft-versus-host-disease (GVHD).

Patients will be randomized biologically into one of 3 arms based upon donor availability: (a) human leukocyte antigen (HLA) genotypic matched sibling donor, (b) HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor, (c) two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Conditions

  • Hemophagocytic Lymphohistiocytosis
  • X-Linked Lymphoproliferative Disorders
  • Chediak-Higashi Syndrome
  • Griscelli Syndrome
  • Immunologic Deficiency Syndromes
  • Langerhans-Cell Histiocytosis

Interventions

PROCEDURE

Stem Cell Transplant

IV on Day 0

DRUG

Fludarabine

30mg/m\^2 IV Day -7 through Day -3

DRUG

Melphalan

140 mg/m\^2 IV Day -1

DRUG

Anti-thymocyte globulin (ATG)

30 mg/kg IV Day -5 through Day -1

DRUG

Campath 1H

0.2 mg/kg IV X 5 days (used as an alternative to Anti-thymocyte globulin (ATG) if unable to tolerate ATG) Day -10 through Day -6

DRUG

Cyclosporin A

2.5 mg/kg IV every 12 hours (adults) or every 8 hours (children \<40 kg) maintaining a level of \>200mg/L Day -3 until Day +180 when, if no GVHD, the dose will be tapered 10% per week beginning on day 181

DRUG

Mycophenolate mofetil

15 mg/kg IV or orally bid and discontinued on Day +45 unless GVHD is present

DRUG

Intravenous immunoglobulin (IVIG)

500 mg/kg IV weekly beginning on Day +7 until Day +100

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Angela Smith, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2012-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00176865 on ClinicalTrials.gov