G-CSF-Treated Donor Bone Marrow Transplant in Treating Patients With Hematologic Disorders

Sponsor

OHSU Knight Cancer Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT00253552

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored.

PURPOSE: This clinical trial is studying how well a G-CSF-treated donor bone marrow transplant works in treating patients with hematologic cancer or noncancer.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Sarcoma	Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: etoposide Drug: methotrexate Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy	N/A

Detailed Description

OBJECTIVES:

Primary

Determine whether granulocyte engraftment can be achieved by day 30 in patients with hematologic disorders undergoing HLA-matched, related-donor, allogeneic bone marrow transplantation using filgrastim (G-CSF)-primed bone marrow.
Determine the incidence of grade II or greater acute graft-versus-host disease (GVHD) in patients treated with this regimen and post-transplantation immunosuppression with cyclosporine and methotrexate.

Secondary

Determine whether platelet and red blood cell engraftment can be achieved in patients treated with this regimen.
Determine the incidence of limited and extensive chronic GVHD in patients treated with this regimen.
Determine the event-free survival of patients treated with this regimen.
Determine the post-transplant immune reconstitution in patients treated with this regimen.

OUTLINE: This is a pilot study.

Mobilization: Donors receive filgrastim (G-CSF) subcutaneously (SC) daily on days -3 to -1 followed by bone marrow collection.
Conditioning regimen: Patients receive 1 of the following conditioning regimens according to their primary disease:
Total-body irradiation and high-dose chemotherapy comprising etoposide and cyclophosphamide
High-dose chemotherapy comprising busulfan and cyclophosphamide
Bone marrow transplantation: Patients receive G-CSF-primed allogeneic bone marrow on day

Patients then receive G-CSF SC beginning on day 5.

Graft-versus-host disease prophylaxis: Patients receive cyclosporine beginning on day -1 and methotrexate on days 1, 3, and 6.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Primary Purpose:

Treatment

Official Title:

A Pilot Study of Using Filgrastim-Primed Bone Marrow in Human Leukocyte Antigen (HLA) Matched Related Donor Allogenetic Bone Marrow Transplantation for Patients With Hematologic Malignancies and Non-Malignancies

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006