Immune Disorder HSCT Protocol

Brief Title

Immune Disorder HSCT Protocol

Official Title

A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Immune Function Disorders Using a Reduced Intensity Preparatory Regime

Brief Summary

      This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will
      establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity
      in patients with immune function disorders. A regimen that maximizes host immune suppression
      is expected to reduce graft rejection and optimize donor cell engraftment.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of participants with donor engraftment

Secondary Outcome

 Major Transplant Related Toxicities

Condition

Immune Deficiency Disorders

Intervention

Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan

Study Arms / Comparison Groups

 Preparative
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

March 2013

Completion Date

March 2024

Primary Completion Date

March 2022

Eligibility Criteria

        Inclusion Criteria:

          -  /= 40

          -  DLCO >/= 40%

          -  LVEF >/=40% or LVSF >/=26%

          -  Serum creatinine < 2x ULN

          -  Liver enzymes 					

Gender

All

Ages

N/A - 21 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01821781

Organization ID

201301135


Responsible Party

Sponsor

Study Sponsor

Washington University School of Medicine


Study Sponsor

, , 


Verification Date

May 2020