G-CSF-Treated Donor Bone Marrow Transplant in Treating Pa... | NCT00253552 | Trialant
NCT00253552
Sponsor
OHSU Knight Cancer Institute
Status
Terminated
Last Update Posted
May 28, 2012Estimated
Enrollment
4Actual
Phase
Not Applicable
Conditions
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Sarcoma
Interventions
filgrastim
busulfan
cyclophosphamide
cyclosporine
etoposide
methotrexate
allogeneic bone marrow transplantation
radiation therapy
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00253552
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000445188
Secondary IDs
ID
Type
Description
Link
OHSU-HEM-04007-L
Other Identifier
OHSU Knight Cancer Institute
OHSU-1381
Other Identifier
OHSU IRB
Brief Title
G-CSF-Treated Donor Bone Marrow Transplant in Treating Patients With Hematologic Disorders
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
Acronym
Not provided
Organization
OHSU Knight Cancer InstituteOTHER
Status Module
Record Verification Date
Jun 2010
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Terminated at request of PI as study was outdated.
Expanded Access Info
No
Start Date
May 2004
Primary Completion Date
May 2006Actual
Completion Date
May 2006Actual
First Submitted Date
Nov 11, 2005
First Submission Date that Met QC Criteria
Nov 11, 2005
First Posted Date
Nov 15, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 24, 2012
Last Update Posted Date
May 28, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
OHSU Knight Cancer InstituteOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
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.
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.
Conditions Module
Conditions
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Sarcoma
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
4Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
filgrastim
Biological
busulfan
Drug
cyclophosphamide
Drug
cyclosporine
Drug
etoposide
Drug
methotrexate
Drug
allogeneic bone marrow transplantation
Procedure
radiation therapy
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
24 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Eneida Nemecek, MD
OHSU Knight Cancer Institute
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
OHSU Knight Cancer Institute
Portland
Oregon
97239-3098
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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