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| Sponsored by: |
University of Pennsylvania |
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00674427 |
Purpose
This study is for patients with relapsed of disease after allogeneic bone marrow
The donor's T cells are activated by exposure to 2 compounds or antibodies that bind (or stick to) two compounds on T cells called CD3 and CD28. When these antibodies stick to both CD3 and CD28 on the T cells, the T cells becomes stimulated (or "activated") and grows. CD3 and CD28 are the coating of a T cell and a T cell is part of the body's immune system.
It is believed that when T cells are exposed to both of antibodies to CD3 and CD28 compounds at the same time, they become activated or "stimulated" and may be more effective in fighting infections or cancer cells. We call this therapy "activated donor lymphocyte infusions, or activated DLI (aDLI)".
This current study is being performed to see whether it is safe and effective to administer higher doses of activated DLI or repeated doses of activated DLI.
All patients will receive standard donor lymphocyte infusions first, and in addition will receive activated donor lymphocytes approximately 12 days later (DLI followed by aDLI). Depending of the response to this treatment, and depending on possible side effects (such as graft-vs-host disease as described below), patients in remission will then receive additional aDLI every 3 months for 4 more times, and patients not in remission within 6-12 weeks will receive higher dose aDLI. The timing of the higher dose aDLI will be determined by your physician depending on your disease and the rate of progression of your disease. The aDLI can be given as early as 6 weeks, or as late as 12 weeks (3 months).
| Condition | Intervention | Phase |
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Chronic Myelogenous Leukemia Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Chronic Lymphocytic Leukemia CML AML ALL MDS NHL CLL |
Biological: CD3/CD28 Activated T cells |
Phase I Phase II |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I/II Trial Of DLI And Activated DLI (ADLI) Followed By Either Repetitive Dosing Of ADLI Or Dose Escalated ADLI For Patients With Relapse After Allogeneic Stem Cell Transplantation |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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CR: Experimental
Subjects who are in CR ater 6-12 weeks after aDLI
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Biological: CD3/CD28 Activated T cells
Subjects in CR 6-12 weeks after the first dose of Activated Donor Lymphocyte Infusion (aDLI) will continue to receive aDLI every 3 months for up to a year.
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Not in CR: Experimental
Subjects not in CR after 6-12 weeks after aDLI
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Biological: CD3/CD28 Activated T cells
Subjects who are not in CR will receive one infusion of high dose aDLI
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Relapsed or persistent advanced malignancy with less than a 50% chance of responding to unstimulated DLI:
a. CML: Relapse with accelerated phase, or blast phase disease b. AML, ALL i. Cytogenetic relapse (less than 5% blasts).
The patient's leukemia-specific chromosome abnormality is detectable by standard cytogenetics in more than 25% of cells at any time greater than day 50 post-transplant.
ii. Hematologic relapse: More than 5% blasts in the marrow or peripheral blood.
c. MDS d. Non-Hodgkin's Lymphoma or Hodgkin's Disease i. Relapse: Recurrent disease by serial physical exam, radiographic studies, or molecular studies. If possible, tumor should be re-biopsied to determine histology and rule out possibility of EBV-related lymphoproliferative disease e. CLL f. Myeloma
Exclusion Criteria:
Contacts and Locations| Contact: Melissa Murter, RN, BSN | 215-746-5811 | mell@mail.med.upenn.edu |
| United States, Pennsylvania | |||||
| University of Pennsylvania | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19104 | |||||
| Contact: Melissa Murter, RN, BSN 215-746-5811 mell@mail.med.upenn.edu | |||||
| University of Pennsylvania |
| Principal Investigator: | David Porter, MD | University of Pennsylvania |
More Information
| Responsible Party: | University of Pennsylvania ( Carl H. June, MD ) |
| Study ID Numbers: | UPCC 20406 |
| First Received: | May 5, 2008 |
| Last Updated: | July 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00674427 |
| Health Authority: | United States: Food and Drug Administration |
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