Allogeneic Hematopoietic Stem Cell Transplantation - Full Text View

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 Tumor Hematological Malignancy	Drug: Fludarabine, Busulfan, Thymoglobulin	Phase II

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Fludarabine Fludarabine monophosphate Busulfan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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.

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:

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

Principal Investigator:	Paillard Catherine, Dr	University Hospital, Clermont-Ferrand

More Information

Responsible Party:	CHU Clermont-Ferrand ( Dr Catherine PAILLARD )
Study ID Numbers:	CHU-0039
First Received:	September 9, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00750126
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Allograft

Children

malignancy

Reduced Intensity Conditioning

Fludarabin

Busulfex

Thymoglobulin

Study placed in the following topic categories:

Hematologic Neoplasms

Hematologic Diseases

Busulfan

Fludarabine

Fludarabine monophosphate

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Myeloablative Agonists

Antineoplastic Agents, Alkylating

Alkylating Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00750126