Clinical Trials Directory

Trials / Completed

CompletedNCT00052520

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

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
37 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALtherapeutic allogeneic lymphocytesGiven IV
BIOLOGICALaldesleukinGiven SC
PROCEDUREperipheral blood stem cell transplantationUndergo transplantation
PROCEDUREallogeneic bone marrow transplantationUndergo transplantation
OTHERlaboratory biomarker analysisCorrelative studies
GENETICgene expression analysisCorrelative studies
OTHERimmunologic techniqueCorrelative studies
OTHERflow cytometryCorrelative studies
GENETICpolymerase chain reactionCorrelative studies
GENETICcytogenetic analysisCorrelative studies
OTHERstaining methodCorrelative studies

Timeline

Start date
2002-09-01
Primary completion
2011-04-01
Completion
2013-06-01
First posted
2003-01-27
Last updated
2017-03-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00052520. Inclusion in this directory is not an endorsement.