Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H
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|ClinicalTrials.gov Identifier: NCT00458250|
Recruitment Status : Completed
First Posted : April 10, 2007
Last Update Posted : November 18, 2008
|First Submitted Date ICMJE||April 7, 2007|
|First Posted Date ICMJE||April 10, 2007|
|Last Update Posted Date||November 18, 2008|
|Study Start Date ICMJE||September 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Engraftment one month after transplantation [ Time Frame: Up to 30 days from transplantation ]|
|Original Primary Outcome Measures ICMJE
||Engraftment one month after transplantation|
|Change History||Complete list of historical versions of study NCT00458250 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||six months survival [ Time Frame: Up to 180 days after transplantation ]|
|Original Secondary Outcome Measures ICMJE
||six months survival|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H|
|Official Title ICMJE||Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H|
Many patients suffering various malignant and non-malignant diseases need hematopoietic stem cell transplantation from a healthy person. In the majority of cases there is no matched related or unrelated donor.
Some researchers have been performed transplantation from semi-matched (haploidentical) related donors with relatively good results.
Chinese researchers have been performed this kind of transplantation using CAMPATH-1H and their reports indicates good results.
Chinese populations have more homogenous genetic background than Iranians. In this project, we are going to study the feasibility of this method of haploidentical transplantation in Iranian patients.
Haploidentical hematopoietic stem cell transplantation is a very important therapeutic intervention for treatment of some genetic disorders and hematological malignancies.
In the majority of cases, there is no matched related or unrelated donor. Haploidentical hematopoietic stem cell transplantation is a promising alternative for critical cases.
To avoid severe graft versus host disease (GVHD), two types of T cell depletion (TCD) had been used: total TCD and partial TCD.
Total TCD has disadvantages such as increased rate of rejection and relapse, and increased rate of infections due to delayed immune reconstitution.
Partial TCD has been done by in vivo and/or in vitro methods. In haploidentical transplantation, donor partial TCD (ex vivo TCD) without recipient TCD increases the rate of rejection and can not prevent severe GVHD successfully.
In vivo TCD by partial depletion of donor and recipient T cells has been done in haploidentical transplantation with good results (to some extent inferior to full matched transplantations) by using CAMPATH, ATG, etc.
Most of these studies have been performed in Chinese and Japanese populations that have more homogenous genetic background than other populations.
In order to study the feasibility of this kind of transplantation in Iranian patients, we defined a project to perform haploidentical hematopoietic stem cell transplantation by using in vivo CAMPATH-1H.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Same as current|
|Actual Study Completion Date||February 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
INCLUSION CRITERIA - RECIPIENT: (all of the following)
INCLUSION CRITERIA - DONOR:
EXCLUSION CRITERIA - RECIPIENT: (ANY OF THE FOLLOWING)
|Ages||2 Years to 50 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Iran, Islamic Republic of|
|Removed Location Countries|
|NCT Number ICMJE||NCT00458250|
|Other Study ID Numbers ICMJE||418-A-1954|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Tehran University of Medical Sciences|
|Collaborators ICMJE||Not Provided|
|PRS Account||Tehran University of Medical Sciences|
|Verification Date||November 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP