Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Phase I/II Study of Adoptive Immunotherapy With CD8+ WT1-Specific CTL Clones for Patients With Advanced MDS, CML, AML or ALL After Allogeneic Hematopoietic Stem Cell Transplant
This phase I/II trial is studying the side effects of biological therapy and to see how well it works in treating patients with advanced myelodysplastic syndrome, chronic myeloid leukemia, acute myeloid leukemia, or acute lymphoblastic leukemia. Biological therapies, including immunotherapy, can potentially be used to stimulate the immune system and stop cancer cells from growing. Immunotherapy given to patients who have undergone donor stem cell transplantation may be a way to eradicate remaining cancer cells
PRIMARY OBJECTIVES:
I. To determine the safety and potential toxicities associated with infusing donor CD8+
cytotoxic T lymphocyte (CTL) clones specific for Wilms' tumor (WT1) in patients who have
relapsed or at a high risk of relapse post transplant for myelodysplastic syndromes (MDS),
chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), or acute lymphoblastic
leukemia (ALL).
SECONDARY OBJECTIVES:
I. To determine the in vivo persistence of transferred T cells and assess migration to the
bone marrow, a predominant site of leukemic relapse.
II. To determine if adoptively transferred WT1-specific T cells mediate antileukemic
activity.
OUTLINE: Donors undergo leukapheresis for stem cell harvest to generate CD8-positive WT1
gene-specific CTL clones at the time of allogeneic stem cell transplantation.
After post-transplantation hematopoietic recovery, patients receive treatment for either
highest-risk disease (prophylactically) or relapsed disease.
Highest-risk disease group: Patients receive CD8-positive WT1 gene-specific CTL clones
intravenously (IV) over 1-2 hours on days 0, 14, and 28. Beginning 2-4 hours after CTL
infusion, patients receive interleukin-2 subcutaneously (SC) twice daily on days 28-42 in
the absence of unacceptable toxicity.
Relapsed-disease group: Some patients with evidence of leukemic relapse may receive standard
salvage chemotherapy prior to donor CTL infusions and then receive CD8-positive WT1
gene-specific CTL clones and interleukin-2 as in the highest-risk group.
Patients in both groups who have progressive disease after complete or partial response to
therapy may be eligible for retreatment with CD8-positive WT1 gene-specific CTL clones.
After completion of study treatment, patients are followed every 3 months for 2 years.
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