- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00750126
Allogeneic Hematopoietic Stem Cell Transplantation (RICE)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Lacarin Patrick
- Phone Number: 04.73.75.11.95
- Email: placarin@chu-clermontferrand.fr
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Recruiting
- Paillard Catherine
-
Contact:
- Paillard Catherine, Dr
- Email: cpaillard@chu-clermontferrand.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary criterion - Hematological reconstitution and chimerism post-transplantation
Time Frame: post-transplantation
|
post-transplantation
|
Secondary Outcome Measures
Outcome 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
Time Frame: post-transplantation
|
post-transplantation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paillard Catherine, Dr, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Hematologic Diseases
- Hematologic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Fludarabine
- Busulfan
- Thymoglobulin
Other Study ID Numbers
- CHU-0039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hematologic Neoplasms
-
St. Jude Children's Research HospitalRecruitingRefractory Hematologic Malignancy | Relapsed Hematologic MalignancyUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingHematologic MalignancyChina
-
Innovent Biologics (Suzhou) Co. Ltd.Recruiting
-
Massachusetts General HospitalRecruiting
-
Fondazione EMN Italy OnlusCompletedHEMATOLOGIC MALIGNANCIESItaly
-
Center for International Blood and Marrow Transplant...National Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedHematologic MalignancyUnited States
-
Rigshospitalet, DenmarkNovo Nordisk A/SCompletedHematologic MalignancyDenmark
-
SecuraBioCompletedHematologic MalignancyUnited States, Italy
-
Duke UniversityActive, not recruitingHematologic MalignancyUnited States
-
St. Petersburg State Pavlov Medical UniversityCompleted
Clinical Trials on Fludarabine, Busulfan, Thymoglobulin
-
The Korean Society of Pediatric Hematology OncologyUnknownAcute Myeloid LeukemiaKorea, Republic of
-
The Korean Society of Pediatric Hematology OncologyCompletedWiskott-Aldrich SyndromeKorea, Republic of
-
University of Illinois at ChicagoCompletedAcute Myeloid Leukemia | Polycythemia Vera | Multiple Myeloma | Myelofibrosis | Acute Leukemia | Chronic Myelogenous Leukemia | Aplastic Anemia | Myeloproliferative Disorder | Hodgkin's Disease | Malignant Lymphoma | Lymphocytic LeukemiaUnited States
-
Nantes University HospitalCompleted
-
Institut Paoli-CalmettesAgence de La BiomédecineCompleted
-
M.D. Anderson Cancer CenterCompletedMyelofibrosisUnited States
-
Nantes University HospitalCompleted
-
Shanghai Jiao Tong University School of MedicineRecruitingAcute Myeloid Leukemia | Myelodysplastic SyndromesChina
-
University of ChicagoCompletedLymphoma | Leukemia | Multiple Myeloma | Myelodysplastic SyndromeUnited States
-
Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsTerminatedLeukemia, Myelocytic, AcuteUnited States