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

NCT00578045 | Withdrawn Phase 1

• 1 other identifier: 67363
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (1)

• The researchers also want to find out what types of side effects, if any, subjects will experience with this treatment.

  12 months

Study Arms (1)

1

EXPERIMENTAL

Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood

Procedure: Transfusion

Interventions

Transfusion PROCEDURE

Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Frits van Rhee, MD, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: July 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

US (1)