Allogeneic Hematopoietic Stem Cell Transplantation

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00750126

Acronym

RICE

Enrollment

Registered

2008-09-10

Start date

2007-04-30

Completion date

2009-04-30

Last updated

2011-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Neoplasms, Solid Tumors

Keywords

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

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

Interventions

DRUGFludarabine, Busulfan, Thymoglobulin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 20 Years

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

Design outcomes

Primary

Measure	Time frame
Primary criterion - Hematological reconstitution and chimerism post-transplantation	post-transplantation

Secondary

Measure	Time frame
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

Countries

France

Contacts

Primary ContactLacarin Patrick

placarin@chu-clermontferrand.fr04.73.75.11.95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026