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Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia

NCT00578266 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-03-24

No results posted yet for this study

Summary

For patients with severe aplastic anemia (SAA) who have failed to respond to immunosuppressive therapy and lack an HLA identical family member, our objectives are to make an initial assessment of the safety and efficacy of allogenic stem cell transplantation from either a matched unrelated donor or a mismatched reacted donor using the conditioning regimen of Cytoxan, reduced total body irradiation (TBI) and Campath IH. The principle measures of safety and efficacy will be :

1. Patient survival probability at 100 days, 1 year and 2 years.
2. Incidence of graft versus host disease (GVHD), as well as incidence of acute GVHD and chronic GVHD within 6 months and 2 years.
3. Engraftment at 6 months, 1 year and 2 years

Conditions

  • Anemia, Aplastic

Interventions

DRUG

Cyclophosphamide,Campath IH and TBI

DAY 5 TREATMENT * 6 5 CYTOXAN 50 mg/kg WITH MESNA * 5 CYTOXAN 50 mg/kg WITH MESNA; * 4 CYTOXAN 50 mg/kgWITH MESNA; CAMPATH 3-10 mg * 3 CYTOXAN 50 mg/kg WITH MESNA; CAMPATH; * 2 TBI; CAMPATH; TACROLIMUS * 1 TBI (second fraction); CAMPATH (am) 0 STEM CELL INFUSION (pm)

Sponsors & Collaborators

Principal Investigators

  • Shakila P. Khan, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2016-08-16
Completion
2016-08-16

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00578266 on ClinicalTrials.gov