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The Effect of Maintaining a Higher Haemoglobin Level on Neutropenia Duration After Bone Marrow Transplantation in Children.


Phase 2
1 Year
18 Years
Not Enrolling
Both
Neutropenia

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Trial Information

The Effect of Maintaining a Higher Haemoglobin Level on Neutropenia Duration After Bone Marrow Transplantation in Children.


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 the risk of contracting bacterial and fungal infections that could be
lethal. It is then important to find ways to accelerate the neutrophil recovery, so patient
survival can be improved.

Studies conducted in the '70s and '80s suggested that if the hemoglobin level could be kept
at a higher level, then the neutrophil recovery would be accelerated. Other studies also
support the hypothesis that if the stem cells do not need to produce red cells because these
are being supplied through transfusions, then the stem cells would differentiate into
non-erythroid cell lines.

As of now, for patients undergoing a bone marrow transplant, it is standard practice to
transfuse with red cells based on the condition of the patient or if the hemoglobin level
falls below 70 g/L. Hematopoietic growth factors have been used to increase the speed of the
neutrophil recovery, but studies conducted so far do not demonstrate that mortality and
length of hospitalization have been reduced by the specific use of G-CSF. In more recent
studies, these agents have been shown to also have negative effects, such as delayed
platelet recovery and impaired immune recovery. In addition, the prophylactic use of G-CSF
was also associated with graft-versus-host disease, treatment-related mortality and death.

In conclusion, this study will determine if maintaining a higher hemoglobin level has an
effect on the neutrophil recovery after allogenic bone marrow transplantation in children.


Inclusion Criteria:



1. 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)

2. Patients planned to undergo a related or unrelated allogeneic bone marrow transplant
for a malignant or benign disease (except for sickle cell disease)

3. 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

4. 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

5. Patient must agree to receive blood transfusion

6. Patient (or their legal guardians) must sign an Informed consent Form

Exclusion Criteria:

1. Patients receiving autologous bone marrow transplant, cord blood transplant or
peripheral stem cell transplant

2. Sickle cell disease (since higher hemoglobin level increases blood viscosity and puts
these patients at risk for stroke)

3. 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)

4. Presence of an allo-antibody directed against red blood cells

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to neutrophil engraftment (defined as the time from transplantation to the first of three consecutive days with a neutrophil count > 0,5 x 109/L, as used in the International Bone Marrow Transplant Registry (IBMTR) criteria).

Outcome Time Frame:

First 100 days post HSCT

Safety Issue:

Yes

Principal Investigator

Michel Duval, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Justine's Hospital

Authority:

Canada: Health Canada and FRSQ (Qu├ębec)

Study ID:

9967

NCT ID:

NCT00937053

Start Date:

June 2009

Completion Date:

June 2015

Related Keywords:

  • Neutropenia
  • Neutropenia
  • Transfusions
  • Hemoglobin
  • Bone marrow transplant
  • Hematopoietic stem cell transplant
  • Neutropenia

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