Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer
This study has been completed.
Sponsor:
Asan Medical Center
Collaborator:
Korea Research Institute of Bioscience & Biotechnology
Information provided by (Responsible Party):
Kyoo-Hyung Lee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00823524
First received: January 14, 2009
Last updated: February 18, 2013
Last verified: February 2013
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Purpose
RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell transplant may help kill any remaining cancer cells after the transplant.
PURPOSE: This phase I/II trial is studying the side effects and best dose of donor natural killer cells when given after a donor stem cell transplant in treating patients with advanced cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Unspecified Adult Solid Tumor, Protocol Specific |
Biological: donor natural killer cell infusion |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
essential thrombocythemia
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
polycythemia vera
primary myelofibrosis
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Fungal Infections
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
U.S. FDA Resources
Further study details as provided by Asan Medical Center:
Primary Outcome Measures:
- Safety [ Time Frame: 15 days to 1 year after transplantation ] [ Designated as safety issue: Yes ]Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion
Secondary Outcome Measures:
- Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival [ Time Frame: 15 days to 1 year ] [ Designated as safety issue: No ]achievement of CR of underlying disease, CR duration
| Enrollment: | 47 |
| Study Start Date: | January 2009 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: donor NK cell infusion
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
|
Biological: donor natural killer cell infusion
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
|
Detailed Description:
OBJECTIVES:
Primary
- To assess the safety of donor natural killer (NK) cell infusion after HLA-mismatched/haploidentical allogeneic hematopoietic stem cell transplantation from a familial donor in patients with advanced malignant disorders.
- To determine the maximum number of donor NK cells that can be safely given to these patients.
Secondary
- To assess the clinical efficacy donor NK cell infusion, in terms of tumor response, response duration, and survival, in patients with progressive or recurrent malignant disorders.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
- Phase I: Patients receive an infusion of donor natural killer (NK) cells on days 18 and 21.
- Phase II: Patients receive an infusion of donor NK cells on days 14 and 21. After completion of study treatment, patients are followed periodically.
Eligibility| Ages Eligible for Study: | 15 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of a malignant disorder (hematologic malignancies or solid tumors)
- Advanced disease
- Has undergone prior allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-mismatched/haploidentical familial donor
Progressive or recurrent disease, as defined by any of the following (phase II):
- Peripheral blood blast > 20% with bone marrow aspirate showing > 5% leukemic cells (in patients with acute leukemia)
- Detection of metaphases in the marrow with the same clonal cytogenetic abnormalities as identified before HSCT (or by FISH markers, if appropriate) (in patients with acute leukemia or high-risk myelodysplastic syndromes [MDS])
- Persistent cytopenia with bone marrow aspirate showing various degrees of dysplasia involving ≥ 1 cell lineage (in patients with high-risk MDS)
- Enlargement of pre-existing measurable lesions by 20% according to RECIST criteria (in patients with solid tumors or lymphoma)
- Appearance of new metastatic lesions, including pleural effusion or ascites, radiologically typical for metastases or confirmed as such by cytology (in patients with solid tumors or lymphoma)
- Measurable disease (phase II)
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Total bilirubin < 3.0 mg/dL
- AST < 5 times upper limit of normal
- Creatinine < 3 mg/dL
- Not pregnant or nursing
- No clinically evident cardiac or pulmonary failure
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823524
Locations
| Korea, Republic of | |
| University of Ulsan, Asan Medical Center | |
| Seoul, Korea, Republic of, 138-736 | |
Sponsors and Collaborators
Asan Medical Center
Korea Research Institute of Bioscience & Biotechnology
Investigators
| Principal Investigator: | Kyoo H. Lee, MD | Asan Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kyoo-Hyung Lee, Professor of Internal Medicine, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT00823524 History of Changes |
| Other Study ID Numbers: | CDR0000632275, AMC-UUCM-2008-0383 |
| Study First Received: | January 14, 2009 |
| Last Updated: | February 18, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Asan Medical Center:
|
accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia 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) atypical chronic myeloid leukemia, BCR-ABL1 negative blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia mast cell leukemia meningeal chronic myelogenous leukemia progressive hairy cell leukemia, initial treatment prolymphocytic leukemia |
recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia stage III adult T-cell leukemia/lymphoma stage III chronic lymphocytic leukemia stage IV adult T-cell leukemia/lymphoma stage IV chronic lymphocytic leukemia T-cell large granular lymphocyte leukemia adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma anaplastic large cell lymphoma |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Nervous System Neoplasms Lymphoma, Large-Cell, Immunoblastic Central Nervous System Neoplasms Myelodysplastic-Myeloproliferative Diseases |
Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Neoplasms by Site Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013