Therapeutic Allogeneic Lymphocytes and Aldesleukin in Treating Patients With High-Risk or Recurrent Myeloid Leukemia After Undergoing Donor Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT00052598|
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : February 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Accelerated Phase Chronic Myelogenous Leukemia Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) 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) Blastic Phase Chronic Myelogenous Leukemia Childhood Chronic Myelogenous Leukemia Childhood Myelodysplastic Syndromes Recurrent Adult Acute Myeloid Leukemia Recurrent Childhood Acute Myeloid Leukemia Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia||Biological: therapeutic allogeneic lymphocytes Biological: aldesleukin Other: laboratory biomarker analysis Other: flow cytometry||Phase 1 Phase 2|
I. To determine the safety and potential toxicities associated with infusing donor CD8+ cytotoxic T lymphocytes (CTL) clones specific for Proteinase 3 (Myeloblastin) in patients with relapse/progression of high risk myeloid leukemias after transplant.
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 proteinase 3 (PR3)-specific T cells mediate antileukemic activity.
Patients receive allogeneic CD8+ PR3-specific CTLs intravenously (IV) over 1-2 hours on days 0, 7, 14, 28, and 49 and aldesleukin subcutaneously (SC) twice daily on days 28-41 and 49-63 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up every 1-3 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Adoptive Immunotherapy With CD8+ Proteinase 3 (Myeloblastin)-Specific CTL Clones for HLA-A2+ Patients With Relapse or Progression of Disease After Allogeneic Hematopoietic Stem Cell Transplant for High Risk Myeloid Leukemias|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||June 2011|
Experimental: Treatment (adoptive immunotherapy)
Patients receive allogeneic CD8+ PR3-specific CTLs IV over 1-2 hours on days 0, 7, 14, 28, and 49 and aldesleukin SC twice daily on days 28-41 and 49-63 in the absence of unacceptable toxicity.
Biological: therapeutic allogeneic lymphocytes
Other Name: ALLOLYMPHBiological: aldesleukin
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: flow cytometry
- Toxicity rate associated with infusing donor CD8+CTL clones specific for PR3 [ Time Frame: From the first CTL infusion to 4 weeks after the final dose of CTL or IL-2 ]
- In vivo persistence of transferred T-cells and assessment of migration to the bone marrow [ Time Frame: Baseline and days +7, +11, +14, +21, and +28 after each CTL infusion ]
- Duration of response as assessed by PCR or cytogenetic analysis of peripheral blood and bone marrow samples [ Time Frame: Days +0, +15, +29, +50, +63, and at approximately 1 month after completion of all therapy ]
- Proportion of responders [ Time Frame: Approximately one month after completion of all therapy ]
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): NCT00052598
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Gunnar Ragnarsson||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|