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Mixed Chimeric Transplantation for Primary Amyloidosis

Primary Purpose

Amyloidosis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
autologous followed by nonmyeloablative allogeneic transplant
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyloidosis focused on measuring Amyloidosis, nonmyeloablative, hematopoietic, cell transplantation

Eligibility Criteria

undefined - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: primary amyloidosis adequate organ function matched sibling donor Exclusion Criteria: evidence of multiple myeloma HIV positive

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Treatment of patients with nonmyeloablative allogeneic transplant for amyloidosis.

    Secondary Outcome Measures

    Toxicity of therapy
    Changes in marrow and serum abnormalities
    Improvement in end-organ function.

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    June 16, 2022
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00186095
    Brief Title
    Mixed Chimeric Transplantation for Primary Amyloidosis
    Official Title
    Mixed Chimeric Transplantation for Primary Amyloidosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Closed, never started.
    Study Start Date
    December 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Stanford University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate the role of nonmyeloablative allogeneic transplantation in Amyloidosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amyloidosis
    Keywords
    Amyloidosis, nonmyeloablative, hematopoietic, cell transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    autologous followed by nonmyeloablative allogeneic transplant
    Primary Outcome Measure Information:
    Title
    Treatment of patients with nonmyeloablative allogeneic transplant for amyloidosis.
    Secondary Outcome Measure Information:
    Title
    Toxicity of therapy
    Title
    Changes in marrow and serum abnormalities
    Title
    Improvement in end-organ function.

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: primary amyloidosis adequate organ function matched sibling donor Exclusion Criteria: evidence of multiple myeloma HIV positive
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keith Stockerl-Goldstein, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Mixed Chimeric Transplantation for Primary Amyloidosis

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