New York, New York 10032

  • Lymphoma

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000487602


NCT ID:

NCT00899119


Secondary ID:

CPMC-AAAB4806


Study Acronym:


Brief Title:

Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia


Official Title:

Autologous Stem Cell Harvesting for Waldenstrom's Macroglobulinemia


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

Unspecified


Reasons Why Stopped:


Study Type:

Observational


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:November 2005
Verification Date:January 2008
Last Changed Date:December 17, 2013
First Received Date:May 9, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of days to adequate stem cell harvest
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:leukapheresis

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Herbert Irving Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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