Maintaining a Higher Level of Haemoglobin: Effect on the White Cells After Bone Marrow Transplantation in Children.

NCT00937053 | Terminated Phase 2 DMC

• 1 other identifier: 9967
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 5

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.

Conditions

Neutropenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  First 100 days post HSCT

Secondary Outcomes (9)

• Time to platelet engraftment (defined as the time from transplantation to the first of three consecutive days with a platelet count > 20 x 109/L, without platelet transfusion 7 days prior (IBMTR criteria)).

  First 100 days post HSCT

• Transfusions given (red cells and platelets)

  First 100 days post HSCT

• Hospitalization length

  2 years

• Immune reconstitution (lymphoid subsets)

  First 100 days post HSCT

• Overall survival

  5 years

Study Arms (2)

Hemoglobin below 120 g/dL

EXPERIMENTAL

Other: Transfusion level 120 g/dL; Other: Platelet transfusion

Hemoglobin below 70 g/dL

ACTIVE COMPARATOR

Other: Transfusion level 70 g/dL; Other: Platelet transfusion

Interventions

Transfusion level 120 g/dL OTHER

Patients whose hemoglobin falls below 120 g/dL will be transfused with red cells within 24 hours.

Hemoglobin below 120 g/dL

Transfusion level 70 g/dL OTHER

Patients whose hemoglobin falls below 70 g/dL will be transfused with red cells within 24 hours

Hemoglobin below 70 g/dL

Platelet transfusion OTHER

Patients whose platelets fall below 10 x 10\*9 will be transfused with platelets

Hemoglobin below 120 g/dL; Hemoglobin below 70 g/dL

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Nancy Robitaille, MD: collaborator

Study Sites (5)

Souther Alberta Children's Cancer Care Program, Calgary

Calgary, Alberta, Canada

Location

Pediatric Bone Marrow Transplant Unit, British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Location

Section of Blood and Marrow Transplant, The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Hematopoietic Stem Cell Transplantation Program, Sainte-Justine Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

Department of Hematology, The Montreal Children's Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Neutropenia

Interventions

Platelet Transfusion

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Michel Duval, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Nancy Robitaille, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2015
• Last Updated: August 4, 2010

Record last verified: 2009-05

Locations

CA (5)