Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia

Lymphoma Clinical Trial

Official title:

Autologous Stem Cell Harvesting for Waldenstrom's Macroglobulinemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00899119
• Other study ID #: CDR0000487602
• Secondary ID: CPMC-AAAB4806
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: December 17, 2013
• Start date: November 2005

Study information

• Verified date: January 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Procedure:
• leukapheresis

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Herbert Irving Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days to adequate stem cell harvest			No