Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia
Primary Purpose
Lymphoma
Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
leukapheresis
Sponsored by
About this trial
This is an observational trial for Lymphoma focused on measuring Waldenström macroglobulinemia
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of Waldenstrom's macroglobulinemia (WM)
- Less than 30% lymphoplasmacytoid cells in bone marrow by histopathology
- Received prior chemotherapy for WM
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC > 2,000/mm³
- Platelet count > 50,000/mm³
- LVEF ≥ 50%
- No organ dysfunction that would preclude future transplantation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Sites / Locations
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Number of days to adequate stem cell harvest
Secondary Outcome Measures
Full Information
NCT ID
NCT00899119
First Posted
May 9, 2009
Last Updated
December 17, 2013
Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00899119
Brief Title
Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia
Official Title
Autologous Stem Cell Harvesting for Waldenstrom's Macroglobulinemia
Study Type
Observational
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Collecting and storing stem cells to study in the laboratory may help doctors learn more about collecting stem cells from patients who have undergone treatment for Waldenstrom's macroglobulinemia.
PURPOSE: This laboratory study is collecting stem cells from patients with Waldenstrom's macroglobulinemia.
Detailed Description
OBJECTIVES:
Harvest and store adequate CD34+ stem cells from patients with Waldenstrom's macroglobulinemia (WM) for potential future use in transplantation strategies.
Evaluate the ability to harvest stem cells after therapy for WM (e.g., fludarabine-based chemotherapy) by evaluating the number of days to adequate harvest.
Collect aliquots of stem cells for future research analysis as part of a WM database project.
OUTLINE: Patients undergo collection of autologous stem cells beginning on day 4 or 5 and continuing until an adequate number of stem cells are collected. Cells are then cryopreserved.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Waldenström macroglobulinemia
7. Study Design
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
leukapheresis
Primary Outcome Measure Information:
Title
Number of days to adequate stem cell harvest
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of Waldenstrom's macroglobulinemia (WM)
Less than 30% lymphoplasmacytoid cells in bone marrow by histopathology
Received prior chemotherapy for WM
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
WBC > 2,000/mm³
Platelet count > 50,000/mm³
LVEF ≥ 50%
No organ dysfunction that would preclude future transplantation
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwen L. Nichols, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Herbert Irving Comprehensive Cancer C
Phone
212-305-8615
12. IPD Sharing Statement
Learn more about this trial
Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia
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