- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00823524
Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer
Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of, 138-736
- University of Ulsan, Asan Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: donor NK cell infusion
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
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give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 15 days to 1 year after transplantation
|
Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion
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15 days to 1 year after transplantation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival
Time Frame: 15 days to 1 year
|
achievement of CR of underlying disease, CR duration
|
15 days to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified adult solid tumor, protocol specific
- primary myelofibrosis
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- 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)
- secondary acute myeloid leukemia
- chronic phase chronic myelogenous leukemia
- primary systemic amyloidosis
- recurrent adult acute myeloid leukemia
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II multiple myeloma
- stage III multiple myeloma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- primary central nervous system non-Hodgkin lymphoma
- refractory chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- intraocular lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- adult grade III lymphomatoid granulomatosis
- adult nasal type extranodal NK/T-cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- post-transplant lymphoproliferative disorder
- cutaneous B-cell non-Hodgkin lymphoma
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- polycythemia vera
- essential thrombocythemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- Waldenström macroglobulinemia
- accelerated phase chronic myelogenous leukemia
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- isolated plasmacytoma of bone
- extramedullary plasmacytoma
- acute undifferentiated leukemia
- atypical chronic myeloid leukemia, BCR-ABL1 negative
- meningeal chronic myelogenous leukemia
- mast cell leukemia
- progressive hairy cell leukemia, initial treatment
- T-cell large granular lymphocyte leukemia
- primary central nervous system Hodgkin lymphoma
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Precancerous Conditions
- Neoplasms
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Disease
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Preleukemia
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Plasmacytoma
- Lymphoproliferative Disorders
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Other Study ID Numbers
- CDR0000632275
- AMC-UUCM-2008-0383
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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