Allogeneic Hematopoietic Stem Cell Transplantation

NCT00750126 | Unknown Phase 2

• 1 other identifier: CHU-0039
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors; Hematologic Neoplasms

Keywords

Allograft; Children; malignancy; Reduced Intensity Conditioning; Fludarabin; Busulfex; Thymoglobulin

Outcome Measures

Primary Outcomes (1)

• Primary criterion - Hematological reconstitution and chimerism post-transplantation

  post-transplantation

Secondary Outcomes (1)

• Secondary criteria - Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions

  post-transplantation

Interventions

Fludarabine, Busulfan, Thymoglobulin DRUG

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

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged less than 20 years old
• Lansky score \> 60%
• Life expectancy greater than 2 months
• Diagnoses:
• Solid tumor or hematological malignancy remaining unresponsive to the reference strategies according to French best practices in pediatrics.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Paillard Catherine

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasms

Interventions

fludarabine; Busulfan; thymoglobulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Paillard Catherine, Dr

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lacarin Patrick

CONTACT

04.73.75.11.95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: April 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 19, 2011

Record last verified: 2011-01

Locations

FR (1)