Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation



Status:Archived
Conditions:Blood Cancer, Women's Studies, Anemia, Hematology
Therapuetic Areas:Hematology, Oncology, Reproductive
Healthy:No
Age Range:Any
Updated:7/1/2011

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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


RATIONALE: 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. PURPOSE: 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


PRIMARY OBJECTIVES: I. To determine the safety and potential toxicities associated with
infusing donor CD8+ CTL clones specific for WT1 in patients who have relapsed or at a high
risk of relapse post transplant for MDS, CML, AML, or 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 Wilms' tumor (WT1) gene-specific cytotoxic
T-lymphocyte (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 Wilms' tumor (WT1) gene-specific CTL clones IV over 1-2 hours
on days 0, 14, and 28. Beginning 2-4 hours after CTL infusion, patients receive
interleukin-2 subcutaneously 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 Wilms' tumor (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 Wilms'
tumor (WT1) gene-specific CTL clones. After completion of study treatment, patients are
followed every 3 months for 2 years.


We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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mi
from
Seattle, WA
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