G-CSF-Treated Donor Bone Marrow Transplant in Treating Patients With Hematologic Disorders
This study has been terminated.
(Terminated at request of PI as study was outdated.)
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00253552
First received: November 11, 2005
Last updated: May 24, 2012
Last verified: June 2010
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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 |
Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: etoposide Drug: methotrexate Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Blood Disorders
Bone Marrow Transplantation
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Soft Tissue Sarcoma
Drug Information available for:
Cyclophosphamide
Busulfan
Methotrexate
Methotrexate sodium
Etoposide
Cyclosporine
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by OHSU Knight Cancer Institute:
| Enrollment: | 4 |
| Study Start Date: | May 2004 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
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 | |
| OHSU Knight Cancer Institute | |
| Portland, Oregon, United States, 97239-3098 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
| Principal Investigator: | Eneida Nemecek, MD | OHSU Knight Cancer Institute |
More Information
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00253552 History of Changes |
| Other Study ID Numbers: | CDR0000445188, OHSU-HEM-04007-L, OHSU-1381 |
| Study First Received: | November 11, 2005 |
| Last Updated: | May 24, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by OHSU Knight Cancer Institute:
|
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 |
Additional relevant MeSH terms:
|
Neoplasms Graft vs Host Disease Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Lymphoma, Large-Cell, Immunoblastic Sarcoma Myelodysplastic-Myeloproliferative Diseases Immune System Diseases |
Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Neoplasms, Connective and Soft Tissue Busulfan |
ClinicalTrials.gov processed this record on May 22, 2013