Status:
TERMINATED
Maintaining a Higher Level of Haemoglobin: Effect on the White Cells After Bone Marrow Transplantation in Children.
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
Nancy Robitaille, MD
Conditions:
Neutropenia
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if maintaining a high hemoglobin level in children that underwent bone marrow transplant will accelerate the neutrophil recovery.
Detailed Description
The investigators know that children requiring bone marrow transplant need to first go through a myeloablative regimen, which induces a neutropenia. The length of the neutropenia has an incidence on t...
Eligibility Criteria
Inclusion
- Patients between 1 year of age and 18 years of age at the time of transplantation (18 years is the upper limit of childhood in CIBMTR definitions)
- Patients planned to undergo a related or unrelated allogeneic bone marrow transplant for a malignant or benign disease (except for sickle cell disease)
- Conditioning regimen must be myeloablative, i.e. include busulfan greater or equal to 12 mg/kg or Total Body Irradiation greater or equal to 10 Gy, except for patients with acquired severe aplastic anemia
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before enrolment in the trial
- Patient must agree to receive blood transfusion
- Patient (or their legal guardians) must sign an Informed consent Form
Exclusion
- Patients receiving autologous bone marrow transplant, cord blood transplant or peripheral stem cell transplant
- Sickle cell disease (since higher hemoglobin level increases blood viscosity and puts these patients at risk for stroke)
- Hematopoietic growth factor (G-CSF, GM-CSF, stem cell factor, erythropoietin) planned before transplantation (post-transplant decision of hematopoietic growth factors administration as required by the patient's condition will be accepted)
- Presence of an allo-antibody directed against red blood cells
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00937053
Start Date
June 1 2009
End Date
June 1 2015
Last Update
August 4 2010
Active Locations (5)
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1
Souther Alberta Children's Cancer Care Program, Calgary
Calgary, Alberta, Canada
2
Pediatric Bone Marrow Transplant Unit, British Columbia Children's Hospital
Vancouver, British Columbia, Canada
3
Section of Blood and Marrow Transplant, The Hospital for Sick Children
Toronto, Ontario, Canada
4
Hematopoietic Stem Cell Transplantation Program, Sainte-Justine Hospital
Montreal, Quebec, Canada, H3T 1C5