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Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
Leukemia, Acute Myelogenous (AML), Leukemia, Acute Lymphocytic (ALL), Leukemia, Chronic Myelogenous (CML), Myelodysplastic Syndrome (MDS) or Non-Hodgkin's Lymphoma (NHL)
and you are
between 1 and 74
years old
This is a medium phase trial determining
the safety and dosage of the new treatment, as well as its efficacy.
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The purpose

Background: - Most patients with acute lymphoblastic leukemia (ALL) and many patients with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML) and non-Hodgkin's lymphoma (NHL) have a protein called Wilm's Tumor 1 (WT1) in their cancer cells. This protein is thought to be able to influence the growth of these cancers. - A vaccine made with the WT1 protein may boost the immune system to help fight these cancers in patients whose cancer cells contain the protein. Objectives: - To determine the safety, effectiveness and side effects of giving the WT1 vaccine and donor white blood cells to patients with AML, ALL, CML or NHL who have previously received standard treatment and undergone stem cell transplantation. - To determine the immune response to the WT1 vaccine and donor white blood cells in these patients and to determine if the response is related to the amount of WT1 protein in the patient's cancer cells. Eligibility: - Patients between 1 and 75 years of age with the blood antigen human leukocyte antigen (HLA-A2) and the WT1 cancer protein who have persistent or recurrent blood cancers after stem cell transplantation. - The prior stem cell transplant donor must be willing to provide additional cells, which will be used to prepare the cellular vaccines and for donor lymphocyte (white blood cell) infusions. Design: - Patients are given the WT1 vaccine every 2 weeks for 6 weeks (weeks 0, 2, 4, 6, 8, 10). Each vaccination consists of two injections in the upper arm or thigh. - On weeks 0, 4 and 8, patients also receive white blood cells from a donor to enhance the immune response. The cells are also given as a 15- to 30-minute infusion through a vein about 1 hour after the vaccine injection. Donor infusions are given only to patients with mild or no graft-vs-host disease resulting from their prior stem cell transplantation. - Periodic physical examinations, blood and urine tests, scans to evaluate disease and other tests as needed are done for 12 months after enrollment in the study.

Provided treatments

  • Drug: WT1 Peptide-Pulsed Dendritic Cells
  • Drug: Donor Lymphocytes
  • Drug: IL-4
  • Drug: KLH
  • Drug: WT1 Peptides
  • Drug: Endotoxin
  • Drug: Diphenhydramine
  • Drug: Acetaminophen
Tris trial is registered with FDA with number: NCT00923910. The sponsor of the trial is National Cancer Institute (NCI) and it is looking for 10 volunteers for the current phase.
Official trial title:
A Pilot Trial of WT1 Peptide-Loaded Allogeneic Dendritic Cell Vaccine and Donor Lymphocyte Infusion for WT1-Expressing Hematologic Malignancies