Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), January 2008

First Received: May 9, 2009 No Changes Posted

Sponsors and Collaborators:	Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00899119

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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Gwen L. Nichols, MD

Herbert Irving Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by National Cancer Institute (NCI):

Waldenstrom macroglobulinemia

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Lymphatic Diseases
Waldenstrom Macroglobulinemia
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Blood Protein Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Lymphatic Diseases
Waldenstrom Macroglobulinemia
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 11, 2009