Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
G-CSF-Treated Donor Bone Marrow Transplant in Treating Patients With Hematologic Disorders
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Oregon Health and Science University Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00253552
  Purpose

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

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Bone Marrow Transplantation Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma Soft Tissue Sarcoma
Drug Information available for: Cyclophosphamide Filgrastim Etoposide Methotrexate Cyclosporin Cyclosporine Granulocyte colony-stimulating factor Etoposide phosphate Busulfan
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2004
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 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.

  Eligibility

Ages Eligible for Study:   up to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253552

Locations
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
Oregon Health and Science University Cancer Institute
Investigators
Principal Investigator: H. Stacy Nicholson, MD, MPH Oregon Health and Science University Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000445188, OHSU-HEM-04007-L, OHSU-1381
Study First Received: November 11, 2005
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00253552  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
graft versus host disease
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
juvenile myelomonocytic leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Cyclosporine
Chronic myelogenous leukemia
Malignant mesenchymal tumor
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Small non-cleaved cell lymphoma
Cyclosporins
Lymphoma, large-cell, immunoblastic
Preleukemia
Hemorrhagic Disorders
Neoplasm Metastasis
Methotrexate
Etoposide
Rhabdomyosarcoma
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Blood Coagulation Disorders
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Acute myelogenous leukemia
Leukemia, Myeloid
Folic Acid
Myelodysplastic myeloproliferative disease
Leukemia, Myeloid, Accelerated Phase
B-cell lymphomas
Sarcoma
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Pathologic Processes
Therapeutic Uses
Syndrome
Antifungal Agents
Abortifacient Agents
Cardiovascular Diseases
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Disease
Immune System Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 14, 2009