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Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00899119
First Posted: May 12, 2009
Last Update Posted: December 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention
Lymphoma Procedure: leukapheresis

Study Type: Observational
Official Title: Autologous Stem Cell Harvesting for Waldenstrom's Macroglobulinemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of days to adequate stem cell harvest

Estimated Enrollment: 40
Study Start Date: November 2005
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899119


Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C    212-305-8615      
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Gwen L. Nichols, MD Herbert Irving Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00899119     History of Changes
Other Study ID Numbers: CDR0000487602
CPMC-AAAB4806
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: December 18, 2013
Last Verified: January 2008

Keywords provided by National Cancer Institute (NCI):
Waldenström macroglobulinemia

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases