Trial of Donor Lymphocyte Infusion (DLI) and Activated DLI Following Relapse After Allogeneic Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT00674427|
Recruitment Status : Terminated (Insufficient funds)
First Posted : May 7, 2008
Last Update Posted : August 17, 2020
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 on 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 or disease||Intervention/treatment||Phase|
|Chronic Myelogenous Leukemia Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Chronic Lymphocytic Leukemia||Biological: CD3/CD28 Activated T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Subjects who are in CR ater 6-12 weeks after aDLI
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.
Experimental: Not in CR
Subjects not in CR after 6-12 weeks after aDLI
Biological: CD3/CD28 Activated T cells
Subjects who are not in CR will receive one infusion of high dose aDLI
- Determining the incidence and severity of acute and chronic GVHD associated with repetitive dosing of aDLI. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674427
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||David Porter, MD||University of Pennsylvania|