Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899119
First received: May 9, 2009
Last updated: December 17, 2013
Last verified: January 2008
  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 [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Gwen L. Nichols, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899119     History of Changes
Other Study ID Numbers: CDR0000487602, CPMC-AAAB4806
Study First Received: May 9, 2009
Last Updated: December 17, 2013
Health Authority: Unspecified

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

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

ClinicalTrials.gov processed this record on August 18, 2014