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UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT00578045
Recruitment Status : Withdrawn (no accrual)
First Posted : December 20, 2007
Last Update Posted : October 26, 2015
Sponsor:
Information provided by:
University of Arkansas

Brief Summary:
The researchers want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Procedure: Transfusion Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies
Study Start Date : July 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood
Procedure: Transfusion
Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood



Primary Outcome Measures :
  1. The researchers on this study want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The researchers also want to find out what types of side effects, if any, subjects will experience with this treatment. [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with advanced hematological malignancies who have failed at least two lines of therapy.
  • Karnofsky performance score > 60, unless due to disease and then > 50.
  • Age > 18 years.
  • An expected survival of > 3 months.
  • Subjects must have signed an IRB-approved consent and been informed about the investigational nature of the study.
  • Cord blood must have negative serology for HIV.
  • Release of cord blood.
  • The nucleated cell count of the CBU shall equal or exceed 1 x 107 per kg of recipient body weight.

Exclusion Criteria:

  • Liver function: total bilirubin > 2x ULN or AST/ALT > 3x ULN.
  • Creatinine > 3.0 mg/dL.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578045


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Frits van Rhee, MD, PhD University of Arkansas

Responsible Party: Frits van Rhee, MD, PhD, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00578045     History of Changes
Other Study ID Numbers: 67363
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases