Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT00052520|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|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 Essential Thrombocythemia Polycythemia Vera 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 Biological: aldesleukin 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||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||June 2013|
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
- 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 ]Assessed by Common Terminology Criteria (CTC) version 3.0.
- Relapse of disease [ Time Frame: Up to 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|