Allogeneic Hematopoietic Stem Cell Transplantation (RICE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Clermont-Ferrand
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00750126
First received: September 9, 2008
Last updated: January 18, 2011
Last verified: January 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Solid Tumors Hematologic Neoplasms |
Drug: Fludarabine, Busulfan, Thymoglobulin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Clermont-Ferrand:
Primary Outcome Measures:
- Primary criterion - Hematological reconstitution and chimerism post-transplantation [ Time Frame: post-transplantation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
study :
Primary criterion
- Hematological reconstitution and chimerism 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
- 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
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients aged less than 20 years old
- Lansky score > 60%
- Life expectancy greater than 2 months
Diagnoses:
3- Solid tumor or hematological malignancy remaining unresponsive to the reference strategies according to French best practices in pediatrics.
4- Malignancies for which allografting is the recognized indication but is contraindicated with myeloablative conditioning.
- Usual criteria for allogeneic grafting (pre-graft profile)
- Having a HLA-identical sibling donor for HLA-A, HLA-B and HLA-DR antigens or a HLA mismatch on only one antigen, or having a 10/10 pheno-identical donor, or compatible cord blood.
- Signed informed consent
Exclusion Criteria:
- Patient presenting rapidly-progressive malignancy
- In cases where the potential donor is related, sibling presenting contraindication against hematopoietic stem cell donation
- Unable to sufficiently understand the treatment and its consequences, even after explanation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750126
Contacts
| Contact: Lacarin Patrick | 04.73.75.11.95 | placarin@chu-clermontferrand.fr |
Locations
| France | |
| Paillard Catherine | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Paillard Catherine, Dr cpaillard@chu-clermontferrand.fr | |
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
| Principal Investigator: | Paillard Catherine, Dr | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | Dr Catherine PAILLARD, CHU Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT00750126 History of Changes |
| Other Study ID Numbers: | CHU-0039 |
| Study First Received: | September 9, 2008 |
| Last Updated: | January 18, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Allograft Children malignancy Reduced Intensity Conditioning |
Fludarabin Busulfex Thymoglobulin |
Additional relevant MeSH terms:
|
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases Busulfan Fludarabine monophosphate Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 16, 2013