Trial of Donor Lymphocyte Infusion (DLI) and Activated DLI Following Relapse After Allogeneic Stem Cell Transplant

Stopped early · Phase 1

Conditions studied: Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Chronic Lymphocytic Leukemia

In brief

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).

Key facts

Study ID

NCT00674427

Run by

University of Pennsylvania

People needed

13

Starts

2008-01-01

Expected to finish

2012-01-01

Last updated by the study team

2020-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior allogeneic stem cell transplant.
• Expected survival > 4 weeks
• Original bone marrow donor available for leukocyte donation.
• Absence of active acute GVHD > grade I, or chronic GVHD.
• Off all immune suppression for GVHD for 28 days (an exception may be made for patients with acute leukemia whose disease is progressing rapidly and a 28 day waiting period after discontinuation of immune suppression is not practical or appropriate).
• Creatinine < 2.5 mg/dl.
• 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

You may not qualify if…

• Active chronic or acute GVHD > grade I.
• Requirement for active immunosuppression to treat GVHD.
• Pregnant or lactating women. The safety of this therapy on unborn children or effects on breast milk are not known.
• Uncontrolled active infection
• Any uncontrolled active medical disorder that would preclude participation as outlined.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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