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Umbilical Cord Blood Transplant for Hematological Malignancies

NCT00891592 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-08-19

No results posted yet for this study

Summary

This protocol will enroll subjects with advanced hematologic malignancies who do not have a suitable related or unrelated donor to undergo a Stem Cell Transplant.

In this study, subjects will undergo a Stem Cell Transplant using Cord Blood. Part of the cord blood will be used for the Stem Cell Transplant and part of the cord blood will be sent to a laboratory in order to grow the T cells (from the cord blood) and increase the activity of the cord blood T cells.

The purpose of this part of the study is to see if it is safe to give study subjects activated T cells made from a small portion of their donor UCB unit immediately after the UCB transplant. Activated T cells have been used safely in stem cell transplantation studies in the past, but they have never been studied UCB transplantation.

Conditions

Interventions

BIOLOGICAL

Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells

Single infusion of Cord Blood Cells AND Single Infusion of ex vivo CD3/CD28 costimulated Umbilical Cord Blood T cells. Table 6: Dose escalation (Dose level CD3+ cell dose) * 1xE5 cells/kg * 2xE6 cells/kg * 3xE7 cells/kg * 4xE8 cells/kg

OTHER

Observation Arm

Single infusion of Cord Blood Cells

Sponsors & Collaborators

Principal Investigators

  • David Porter, MD · University of Pennsylvania

  • Elizabeth Hexner, MD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-11-30
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00891592 on ClinicalTrials.gov