Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia

NCT ID: NCT00899119

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma

Keywords

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Waldenström macroglobulinemia

Interventions

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leukapheresis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Herbert Irving Comprehensive Cancer Center

OTHER

Sponsor Role lead

Principal Investigators

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Gwen L. Nichols, MD

Role: STUDY_CHAIR

Herbert Irving Comprehensive Cancer Center

Locations

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Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Clinical Trials Office - Herbert Irving Comprehensive Cancer C

Role: primary

Other Identifiers

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CPMC-AAAB4806

Identifier Type: -

Identifier Source: secondary_id

CDR0000487602

Identifier Type: -

Identifier Source: org_study_id