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
Sponsor:
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
  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:
    Drug: Fludarabine, Busulfan, Thymoglobulin

    study :

    • 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
Detailed Description:

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 April 21, 2014