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

Phase 1

Withdrawn

• Conditions: Multiple Myeloma
• Interventions: Procedure: Transfusion

• Registration Number: NCT00578045
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-20
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Transfusion	Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The researchers also want to find out what types of side effects, if any, subjects will experience with this treatment.	12 months

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States