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.
N/A
20 Years
Both
Solid Tumors, Hematologic Neoplasms
Trial Information
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.
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary criterion - Hematological reconstitution and chimerism post-transplantation
Outcome Time Frame:
post-transplantation
Safety Issue:
Yes
Principal Investigator
Paillard Catherine, Dr
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Clermont-Ferrand
Authority:
France: Ministry of Health
Study ID:
CHU-0039
NCT ID:
NCT00750126
Start Date:
April 2007
Completion Date:
April 2009
Related Keywords:
- Solid Tumors
- Hematologic Neoplasms
- Allograft
- Children
- malignancy
- Reduced Intensity Conditioning
- Fludarabin
- Busulfex
- Thymoglobulin
- Neoplasms
- Hematologic Neoplasms
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