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

University of Arkansas

Status and phase: Withdrawn; Phase 1

Conditions: Multiple Myeloma

Treatments: Procedure: Transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00578045

67363

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Procedure: Transfusion