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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00826 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P01CA018029 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I/II trial is studies the side effects of giving therapeutic allogeneic lymphocytes together with aldesleukin and to see how well it works in treating patients with high-risk or recurrent myeloid leukemia after undergoing donor stem cell transplant. Biological therapies, such as therapeutic autologous lymphocytes, may stimulate the immune system in different ways and stop cancer cells from growing. Aldesleukin may stimulate the white blood cells to kill cancer cells. Giving therapeutic autologous lymphocytes together with aldesleukin may kill more cancer cells
PRIMARY OBJECTIVES:
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.
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 proteinase 3 (PR3)-specific T cells mediate antileukemic activity.
OUTLINE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (adoptive immunotherapy) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic allogeneic lymphocytes | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity rate associated with infusing donor CD8+CTL clones specific for PR3 | From the first CTL infusion to 4 weeks after the final dose of CTL or IL-2 |
| Measure | Description | Time Frame |
|---|---|---|
| In vivo persistence of transferred T-cells and assessment of migration to the bone marrow | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Ragnarsson | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| aldesleukin | Biological | Given SC |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| flow cytometry | Other | Correlative studies |
|
| Days +0, +15, +29, +50, +63, and at approximately 1 month after completion of all therapy |
| Proportion of responders | Approximately one month after completion of all therapy |
| ID | Term |
|---|---|
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D000013 | Congenital Abnormalities |
| D001752 | Blast Crisis |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
| D007376 | Interleukin-2 |
| D005434 | Flow Cytometry |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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