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

• Sponsor: King Faisal Specialist Hospital & Research Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00531635
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Duration (Months): 119
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jul 1, 2002
• Anticipated Primary Completion Date: Jun 1, 2012
• Anticipated Study Completion Date: Jun 1, 2012

Outcome Measures

Primary Outcome Measures

1. Efficacy [2001-2012]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	KFSH&RC	Riyadh		Saudi Arabia	11211

Sponsors and Collaborators

• King Faisal Specialist Hospital & Research Center

Investigators

• Principal Investigator: Mahmoud Aljurf, MD, KFSH&RC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: King Faisal Specialist Hospital & Research Center
• ClinicalTrials.gov Identifier: NCT00531635
• Other Study ID Numbers: RAC#2001-051
• First Posted: Sep 19, 2007
• Last Update Posted: Dec 13, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by King Faisal Specialist Hospital & Research Center: Mixed hemopoietic chimerism, Fludarabine, TBI, PBSC, immunosuppression, Mycophenolate Mofetil
• Additional relevant MeSH terms: Mycophenolic Acid

Study Results

No Results Posted as of Dec 13, 2011