Allogeneic Hematopoietic Stem Cell Transplantation

Phase 2

• Conditions: Solid Tumors; Hematologic Neoplasms

• Registration Number: NCT00750126
• Lead Sponsor: University Hospital, Clermont-Ferrand

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

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-09-09
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-18
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary criterion - Hematological reconstitution and chimerism post-transplantation	post-transplantation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Paillard Catherine; 🇫🇷 Clermont-Ferrand, France