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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by King Faisal Specialist Hospital & Research Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00531635
First received: September 17, 2007
Last updated: December 11, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil
Drug: Mycophenolate Mofetil
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 2001-2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: July 2002
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mycophenolate Mofetil
    Induction of Mixed Hemopoietic Chimerism in Patients Using Mycophenolate Mofetil
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531635

Contacts
Contact: Mahmoud AlJurf, MD 966-1-4647272 ext 24586 maljurf@kfshrc.edu.sa
Contact: Ed Colcol

Locations
Saudi Arabia
KFSH&RC Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Mahmoud Aljurf, MD    966-1-4647272 ext 24586      
Contact: Ed Colcol    966-1-4647272 ext 38015    colcol@kfshrc.edu.sa   
Principal Investigator: Mahmoud Aljurf, MD         
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Mahmoud Aljurf, MD KFSH&RC
  More Information

No publications provided

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT00531635     History of Changes
Other Study ID Numbers: RAC#2001-051
Study First Received: September 17, 2007
Last Updated: December 11, 2011
Health Authority: ORA, KFSH&RC: Saudi Arabia

Keywords provided by King Faisal Specialist Hospital & Research Center:
Mixed hemopoietic chimerism, Fludarabine, TBI, PBSC, immunosuppression, Mycophenolate Mofetil

Additional relevant MeSH terms:
Mycophenolate mofetil
Fludarabine monophosphate
Mycophenolic Acid
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 22, 2014