Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study
Phase 1/Phase 2
15 Years
75 Years
15 Years
75 Years
Not Enrolling
Both
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
Both
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
Trial Information
Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety
Outcome Description:
Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion
Outcome Time Frame:
15 days to 1 year after transplantation
Safety Issue:
Yes
Principal Investigator
Kyoo H. Lee, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Asan Medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
CDR0000632275
NCT ID:
NCT00823524
Start Date:
January 2009
Completion Date:
February 2013
Related Keywords:
- 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
- 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
- angioimmunoblastic T-cell lymphoma
- splenic marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- stage IV mycosis fungoides/Sezary syndrome
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- intraocular lymphoma
- primary central nervous system non-Hodgkin lymphoma
- primary central nervous system Hodgkin lymphoma
- post-transplant lymphoproliferative disorder
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- primary myelofibrosis
- essential thrombocythemia
- polycythemia vera
- extramedullary plasmacytoma
- isolated plasmacytoma of bone
- stage II multiple myeloma
- stage III multiple myeloma
- primary systemic amyloidosis
- refractory multiple myeloma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- cutaneous B-cell non-Hodgkin lymphoma
- Waldenström macroglobulinemia
- unspecified adult solid tumor, protocol specific
- 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
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