Allogeneic Hematopoietic Stem Cell Transplantation (RICE)
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|ClinicalTrials.gov Identifier: NCT00750126|
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : September 10, 2008
Last Update Posted : January 19, 2011
To assess the engraftment of hematopoietic stem cells following reduced-intensity conditioning in children presenting with solid tumors or hematological malignancy by evaluating post-transplantation chimerism and hematological reconstitution.
To study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post-transplantation To study the effectiveness of the protocol on tumor response.
To study overall survival.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors Hematologic Neoplasms||Drug: Fludarabine, Busulfan, Thymoglobulin||Phase 2|
- Hematological reconstitution and chimerism post-transplantation
- Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
- Analysis of variations in post-transplantation immunological function profiles
- Median duration of response in therapy-responsive patients and median duration of stability in stabilized patients
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study on Allogeneic Hematopoietic Stem Cell Transplantation Following Fludarabine-Busulfan-ALS-based Reduced-intensity Conditioning in Children With Hematological Malignancy or Solid Tumor Not Responding to Standard Therapy or for Which the Indication for Allograft is Maintained But Cannot be Carried Out Due to the Toxicity Involved in Myeloablative Conditioning.|
|Study Start Date :||April 2007|
|Estimated Primary Completion Date :||April 2009|
|Estimated Study Completion Date :||April 2009|
Drug: Fludarabine, Busulfan, Thymoglobulin
- acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post transplantation
- the effectiveness of the protocol on tumor response
- overall survival
- Primary criterion - Hematological reconstitution and chimerism post-transplantation [ Time Frame: post-transplantation ]
- Secondary criteria - Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions [ Time Frame: post-transplantation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750126
|Contact: Lacarin Patrickfirstname.lastname@example.org|
|Clermont-Ferrand, France, 63003|
|Contact: Paillard Catherine, Dr email@example.com|
|Principal Investigator:||Paillard Catherine, Dr||University Hospital, Clermont-Ferrand|