Human Cord Blood Transplantation in Advanced Hematological Malignancies

This study has been withdrawn prior to enrollment.
(no accrual)
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00578045
First received: December 18, 2007
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Multiple Myeloma
Procedure: Transfusion
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 10
Study Start Date: July 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Frits van Rhee, MD, PhD, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00578045     History of Changes
Other Study ID Numbers: 2006-28
Study First Received: December 18, 2007
Last Updated: May 3, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 23, 2014