Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil

December 11, 2011 updated by: King Faisal Specialist Hospital & Research Center

Induction of mixed hemopoietic chimerism in patients using Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA & Mycophenolate Mofetil

Study Overview

Status

Unknown

Conditions

Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil

Intervention / Treatment

Drug: Mycophenolate Mofetil

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Saudi Arabia
- - Riyadh, Saudi Arabia, 11211
    - Recruiting
    - KFSH&RC
    - Contact:
      
      Mahmoud Aljurf, MD
      
      Phone Number: 24586 966-1-4647272
    - Contact:
      
      Ed Colcol
      
      Phone Number: 38015 966-1-4647272
      
      Email: colcol@kfshrc.edu.sa
    - Principal Investigator:
      
      Mahmoud Aljurf, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients receiving Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA & Mycophenolate Mofetil.

Exclusion Criteria:

Uncontrolled major medical illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy Time Frame: 2001-2012	2001-2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Faisal Specialist Hospital & Research Center

Investigators

Principal Investigator: Mahmoud Aljurf, MD, KFSH&RC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

September 17, 2007

First Submitted That Met QC Criteria