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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00253552
• Other study ID #: CDR0000445188
• Secondary ID: OHSU-HEM-04007-L
• Status: Terminated
• Phase: N/A
• First received: November 11, 2005
• Last updated: May 24, 2012
• Start date: May 2004
• Est. completion date: May 2006

Study information

• Verified date: June 2010
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 0. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of hematologic malignancy or nonmalignancy

• Candidate for matched, related-donor, allogeneic bone marrow transplantation

• Availability of an HLA-matched (6/6) related donor

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2 OR

• Karnofsky or Lansky 70-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No significant functional deficit of any major organ

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior stem cell transplantation

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Graft Versus Host Disease
• Graft vs Host Disease
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia
• Sarcoma

Intervention

Biological:
• filgrastim

Drug:
• busulfan

• cyclophosphamide

• cyclosporine

• etoposide

• methotrexate

Procedure:
• allogeneic bone marrow transplantation

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,