Donor Bone Marrow Transplant in Treating Young Patients With Cancer or a Non-Cancerous Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00118326
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : May 14, 2010
Information provided by:
Fred Hutchinson Cancer Research Center

July 8, 2005
July 11, 2005
May 14, 2010
August 2003
Not Provided
Safety and feasibility
Not Provided
Complete list of historical versions of study NCT00118326 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Donor Bone Marrow Transplant in Treating Young Patients With Cancer or a Non-Cancerous Disease
Feasibility of Granulocyte-Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow From Pediatric Donors as a Stem Cell Source for Allogeneic Bone Marrow Transplant

RATIONALE: A bone marrow transplant from a brother or sister may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Colony-stimulating factors, such as G-CSF, cause the body to make blood cells. Giving G-CSF to the donor may help the body make more stem cells that can be collected for bone marrow transplant and may cause fewer side effects in the patient after the transplant.

PURPOSE: This phase I/II trial is studying the side effects of donor bone marrow transplant and to see how well it works in treating young patients with cancer or a non-cancerous disease.



  • Determine the safety and feasibility of filgrastim (G-CSF)-mobilized bone marrow from an HLA-identical pediatric sibling donor as a stem cell source for pediatric patients undergoing allogeneic bone marrow transplantation for malignant or non-malignant disease.


  • Determine the time to neutrophil and platelet engraftment, number of red blood cell and platelet transfusions, number of febrile days, and number of hospitalization days in patients treated with this regimen.
  • Determine the number of nucleated cells and CD34-positive cells, absolute lymphocyte count, and lymphocyte subsets (CD3/CD4/CD8) in G-CSF-mobilized bone marrow from these donors.

OUTLINE: This is a multicenter, pilot study.

Donors receive filgrastim (G-CSF) subcutaneously once daily on days -4 to 0. Donors then undergo standard bone marrow harvest on day 0.

Patients receive pre-transplantation conditioning and graft-versus-host disease prophylaxis according to the disease for which the patient is being treated and the treatment plan or clinical trial for which the patient is enrolled on. Patients undergo allogeneic bone marrow transplantation on day 0.

After completion of bone marrow harvest, donors are followed at 7 and 30 days. After completion of study treatment, patients are followed for 100 days post-transplantation and then periodically thereafter.

PROJECTED ACCRUAL: A total of 80 participants (40 donors and 40 patients) will be accrued for this study within 18 months.

Phase 1
Phase 2
Primary Purpose: Treatment
  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Neuroblastoma
  • Sarcoma
  • Biological: filgrastim
  • Procedure: allogeneic bone marrow transplantation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided
May 2007
Not Provided


  • Patients (recipients):

    • Undergoing a myeloablative or nonmyeloablative allogeneic bone marrow transplantation for 1 of the following diseases:

      • Hematologic malignancy
      • Non-hematologic malignancy
      • Non-malignant disease
    • Not undergoing T-cell depleted bone marrow transplantation
  • Donors:

    • Healthy sibling of a patient meeting eligibility requirements for this protocol
    • HLA-identically matched with patient



  • 18 and under (patient and donor)

Performance status

  • Karnofsky 90-100% (donor) OR
  • Lansky 90-100% (donor)

Life expectancy

  • Not specified


  • No sickle cell anemia (donor)


  • Not specified


  • Not specified


  • HIV negative (patient and donor)
  • No uncontrolled bacterial, viral, fungal, or parasitic infection (donor)
  • No potentially life threatening autoimmune disease (donor)


  • Not pregnant or nursing (patient and donor)
  • Fertile patients must use effective contraception (patient)
  • No other illness that would severely limit life expectancy (patient)
  • No pre-existing medical condition that would confer a high risk for bone marrow donation (donor)
  • No medical condition or psychiatric trait that would preclude G-CSF administration or bone marrow harvesting (donor)


Biologic therapy

  • More than 4 years since prior allogeneic blood transfusion (donor)
  • No concurrent growth factors post-transplantation (donor)


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • Concurrent participation in another treatment clinical trial allowed provided the use of filgrastim (G-CSF)-mobilized bone marrow is not excluded (patient)
  • No other concurrent investigational agents (donor)
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000430709 ( Registry Identifier: PDQ )
Not Provided
Not Provided
Not Provided
Not Provided
Fred Hutchinson Cancer Research Center
Not Provided
Principal Investigator: Ann E. Woolfrey, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP