Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
B-cell Adult Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
Childhood Chronic Myelogenous Leukemia
Childhood Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts
Refractory Anemia With Excess Blasts in Transformation
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
T-cell Adult Acute Lymphoblastic Leukemia
T-cell Childhood Acute Lymphoblastic Leukemia
Biological: therapeutic allogeneic lymphocytes
Procedure: peripheral blood stem cell transplantation
Procedure: allogeneic bone marrow transplantation
Other: laboratory biomarker analysis
Genetic: gene expression analysis
Other: immunologic technique
Other: flow cytometry
Genetic: polymerase chain reaction
Genetic: cytogenetic analysis
Other: staining method
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Toxicity rate associated with infusing donor CD8+ CTL clones specific for WT1 in patients at high risk for post transplant relapse of CML, AML, or ALL [ Time Frame: Up to 4 weeks after the final dose of CTL ] [ Designated as safety issue: Yes ]Assessed by Common Terminology Criteria (CTC) version 3.0.
- Relapse of disease [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Patients achieving complete remission with chemotherapy and T cell infusions will be followed to determine the duration of response. The proportion of responders will be estimated with associated confidence intervals. Duration of remission will be summarized using time-to-event methods, which will allow estimates to be made while some patients remain in remission.
|Study Start Date:||September 2002|
|Study Completion Date:||June 2013|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
See Detailed Description
Biological: therapeutic allogeneic lymphocytes
Other Name: ALLOLYMPHBiological: aldesleukin
Other Names:Procedure: peripheral blood stem cell transplantation
Other Names:Procedure: allogeneic bone marrow transplantation
Other Names:Other: laboratory biomarker analysis
Correlative studiesGenetic: gene expression analysis
Correlative studiesOther: immunologic technique
Other Names:Other: flow cytometry
Correlative studiesGenetic: polymerase chain reaction
Other Name: PCRGenetic: cytogenetic analysis
Correlative studiesOther: staining method
Other Name: Staining
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052520
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Merav Bar||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|