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Allogeneic Hematopoietic Stem Cell Transplantation (RICE)

Primary Purpose

Solid Tumors, Hematologic Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Fludarabine, Busulfan, Thymoglobulin
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors focused on measuring Allograft, Children, malignancy, Reduced Intensity Conditioning, Fludarabin, Busulfex, Thymoglobulin

Eligibility Criteria

undefined - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Paillard CatherineRecruiting

Outcomes

Primary Outcome Measures

Primary criterion - Hematological reconstitution and chimerism post-transplantation

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

Full Information

First Posted
September 9, 2008
Last Updated
January 18, 2011
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT00750126
Brief Title
Allogeneic Hematopoietic Stem Cell Transplantation
Acronym
RICE
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Hematologic Neoplasms
Keywords
Allograft, Children, malignancy, Reduced Intensity Conditioning, Fludarabin, Busulfex, Thymoglobulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fludarabine, Busulfan, Thymoglobulin
Intervention Description
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
Primary Outcome Measure Information:
Title
Primary criterion - Hematological reconstitution and chimerism post-transplantation
Time Frame
post-transplantation
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lacarin Patrick
Phone
04.73.75.11.95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paillard Catherine, Dr
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paillard Catherine
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paillard Catherine, Dr
Email
cpaillard@chu-clermontferrand.fr

12. IPD Sharing Statement

Learn more about this trial

Allogeneic Hematopoietic Stem Cell Transplantation

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