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

Lymphoma Clinical Trial

Official title:

Feasibility of Granulocyte-Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow From Pediatric Donors as a Stem Cell Source for Allogeneic Bone Marrow Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118326
• Other study ID #: 1802.00
• Secondary ID: FHCRC-1802.00PBM
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 8, 2005
• Last updated: May 12, 2010
• Start date: August 2003
• Est. completion date: May 2007

Study information

• Verified date: May 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

OBJECTIVES:

Primary

• 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.

Secondary

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age

• 18 and under (patient and donor)

Performance status

• Karnofsky 90-100% (donor) OR

• Lansky 90-100% (donor)

Life expectancy

• Not specified

Hematopoietic

• No sickle cell anemia (donor)

Hepatic

• Not specified

Renal

• Not specified

Immunologic

• HIV negative (patient and donor)

• No uncontrolled bacterial, viral, fungal, or parasitic infection (donor)

• No potentially life threatening autoimmune disease (donor)

Other

• 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)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 years since prior allogeneic blood transfusion (donor)

• No concurrent growth factors post-transplantation (donor)

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• 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)

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Cancer
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Neuroblastoma
• Preleukemia
• Sarcoma

Intervention

Biological:
• filgrastim

Procedure:
• allogeneic bone marrow transplantation

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and feasibility			Yes