|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date † | April 29, 2009 | ||||||||
| Last Updated Date | April 30, 2009 | ||||||||
| Start Date † | January 2009 | ||||||||
| Current Primary Outcome Measures † |
Dose limiting toxicity (DLT) is defined as grade 4 acute GVHD within the first 90 days following infusion. [ Time Frame: 90 Days post Transplant ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00891592 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Umbilical Cord Blood Transplant for Hematological Malignancies | ||||||||
| Official Title † | A Phase 1 Dose Escalation Study of Infusion of ex Vivo cd3/cd28 Costimulated Umbilical Cord Blood-Derived t Cells in Adults Undergoing Transplantation for Advanced Hematologic Malignancies | ||||||||
| Brief 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, subject 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 grown 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. |
||||||||
| Detailed Description | The main study intervention includes CD3/CD28 ex vivo costimulated T cells derived from a thawed umbilical cord blood unit, co-infused following a myeloablative conditioning regimen. Activated T cells are T cells that have been activated in the laboratory by exposure to 2 compounds or molecules called CD3 and CD28; when T cells are exposed to both of these compounds at the same time, they become activated or "stimulated" and may be more effective in fighting infections, cancer cells, and promoting the recovery of red cells, white cells, and platelets after transplantation. At the Hospital of the University of Pennsylvania, activated T cells are prepared at the Clinical Cell and Vaccine Production Facility, also known as the CVPF. |
||||||||
| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition † |
|
||||||||
| Intervention † |
|
||||||||
| Study Arms / Comparison Groups |
|
||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Estimated Enrollment † | 36 | ||||||||
| Estimated Completion Date | January 2011 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria.
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 21 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
|
||||||||
| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00891592 | ||||||||
| Responsible Party | Carl H. June, MD ; Director, Translational Research Programs, Abramson Cancer Center, Professor of Pathology and Laboratory Medicine, University of Pennsylvania | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of Pennsylvania | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
|
||||||||
| Information Provided By | University of Pennsylvania | ||||||||
| Verification Date | April 2009 | ||||||||
|
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
|||||||||
