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Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer

Primary Purpose

Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

donor natural killer cell infusion

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Ulsan, Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

donor NK cell infusion

Arm Description

give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation

Outcomes

Primary Outcome Measures

Safety

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

achievement of CR of underlying disease, CR duration

Full Information

NCT ID

NCT00823524

First Posted

January 14, 2009

Last Updated

February 18, 2013

Sponsor

Asan Medical Center

Collaborators

Korea Research Institute of Bioscience & Biotechnology

1. Study Identification

Unique Protocol Identification Number

NCT00823524

Brief Title

Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer

Official Title

Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

Collaborators

Korea Research Institute of Bioscience & Biotechnology

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

donor NK cell infusion

Arm Type

Experimental

Arm Description

give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation

Intervention Type

Biological

Intervention Name(s)

donor natural killer cell infusion

Intervention Description

give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation

Primary Outcome Measure Information:

Title

Safety

Description

Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion

Time Frame

15 days to 1 year after transplantation

Secondary Outcome Measure Information:

Title

Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival

Description

achievement of CR of underlying disease, CR duration

Time Frame

15 days to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyoo H. Lee, MD

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Ulsan, Asan Medical Center

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

12. IPD Sharing Statement

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Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer

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