Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia

December 17, 2013 updated by: Herbert Irving Comprehensive Cancer Center

Autologous Stem Cell Harvesting for Waldenstrom's Macroglobulinemia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
        • Contact:
          • Clinical Trials Office - Herbert Irving Comprehensive Cancer C
          • Phone Number: 212-305-8615

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of days to adequate stem cell harvest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herbert Irving Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Gwen L. Nichols, MD, Herbert Irving Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000487602
  • CPMC-AAAB4806

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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