CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Fludarabine +7 moredrug
Likely dose
Fludarabine 30 mg/m² IV daily (Days -7 to -3), Melphalan 140 mg/m² IV (Day -1), and Anti-thymocyte globulin 30 mg/kg IV daily (Days -5 to -1) or Campath 1H 0.2 mg/kg IV daily (Days -10 to -6)AI-extracted
Key inclusion· 5
  • ✓Age 0-35 years with immunodeficiency or histiocytic disorder and acceptable stem cell donor
  • ✓Histiocytic disorders (HLH of any etiology or refractory Langerhans cell histiocytosis) not eligible for myeloablative transplant
  • ✓Immunodeficiency with residual immune function not requiring fully myeloablative regimen or ineligible for standard myeloablative regimen (SCID or other T cell defects)
  • ✓Immunodeficiency with poor outcome on prior myeloablative SCT (CVID, WAS if >5 years, ataxia telangiectasia)
Key exclusion· 6
  • ✕Karnofsky or Lansky performance score <70
  • ✕Glomerular filtration rate <30% predicted
  • ✕Cardiac function <50% normal by echocardiogram
  • ✕Serum creatinine >2x normal for age/weight

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00176865
NCT00176865Phase 2Completed
CompareCT.gov

Allogeneic Hematopoietic Stem Cell Transplant for Patients With Immunologic or Histiocytic Disorders Using a Non-Myeloablative Preparative Regimen to Achieve Stable Mixed Chimerism

Masonic Cancer Center, University of Minnesota·interventional·Posted Sep 15, 2005·Updated Dec 28, 2017

In Brief

A Phase 2 clinical trial evaluating Stem Cell Transplant, Fludarabine, and 6 other interventions for Hemophagocytic Lymphohistiocytosis and 5 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophagocytic Lymphohistiocytosis, X-Linked Lymphoproliferative Disorders, Chediak-Higashi Syndrome, Griscelli Syndrome, Immunologic Deficiency Syndromes, Langerhans-Cell Histiocytosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartAug 1, 2002
Primary CompletionAug 1, 2012
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 20.8 years ago

Interventions

Stem Cell Transplantprocedure

IV on Day 0

Fludarabinedrug

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

Melphalandrug

140 mg/m\^2 IV Day -1

Anti-thymocyte globulin (ATG)drug

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

Campath 1Hdrug

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

Cyclosporin Adrug

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

Mycophenolate mofetildrug

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

Intravenous immunoglobulin (IVIG)drug

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