Bone Marrow and Peripheral Stem Cell Transplantation in T... | NCT00004232 | Trialant
NCT00004232
Sponsor
Northwestern University
Status
Completed
Last Update Posted
Jun 1, 2012Estimated
Enrollment
Not provided
Phase
Phase 1
Conditions
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous/Nonmalignant Condition
Interventions
filgrastim
cyclosporine
methylprednisolone
prednisone
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00004232
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NU FDA96H4
Secondary IDs
ID
Type
Description
Link
NU-96H4
NCI-G99-1660
Brief Title
Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Official Title
Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies
Acronym
Not provided
Organization
Northwestern UniversityOTHER
Status Module
Record Verification Date
May 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 1999
Primary Completion Date
Oct 2002Actual
Completion Date
Oct 2002Actual
First Submitted Date
Jan 28, 2000
First Submission Date that Met QC Criteria
May 8, 2003
First Posted Date
May 9, 2003Estimated
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 31, 2012
Last Update Posted Date
Jun 1, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Northwestern UniversityOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of bone marrow and peripheral stem cell transplantation in treating patients who have hematologic cancer.
Detailed Description
OBJECTIVES:
Determine the toxicity of unmanipulated bone marrow augmented with CD34+ enriched peripheral blood stem cells in patients with hematologic malignancies undergoing allogeneic transplantation.
Evaluate this treatment regimen in terms of kinetics of hematopoietic engraftment, infection, severity of graft-vs-host disease, relapse rate, and cost effectiveness in this patient population.
OUTLINE: Patients undergo allogeneic transplantation comprising unmanipulated bone marrow with filgrastim (G-CSF)-mobilized, CD34+ enriched peripheral blood stem cells on day 0.
Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65. Patients also receive G-CSF subcutaneously daily until blood counts recover.
Patients are followed weekly for 3 months, at 6 months and 1 year, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 30-60 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
Precancerous/Nonmalignant Condition
Keywords
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
monoclonal gammopathy of undetermined significance
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
Burkitt lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
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
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
filgrastim
Biological
cyclosporine
Drug
methylprednisolone
Drug
prednisone
Drug
allogeneic bone marrow transplantation
Procedure
peripheral blood stem cell transplantation
Procedure
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosed hematologic malignancy that is eligible for an active allogeneic bone marrow transplantation protocol and leukemia, lymphoma, myeloma, and aplastic anemia treatment protocols
HLA-identical or one antigen-mismatched related donor
PATIENT CHARACTERISTICS:
Age:
10 to 65
Performance status:
Not specified
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Not specified
Renal:
Not specified
Other:
No known sensitivity to E. coli derivatives
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
10 Years
Maximum Age
65 Years
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Richard K. Burt, MD
Robert H. Lurie Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago
Illinois
60611-3013
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
stage 0 chronic lymphocytic leukemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
untreated childhood acute lymphoblastic leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission