NCT00569283

Brief Summary

RATIONALE: Giving donor natural killer cells to patients who have undergone donor bone marrow transplant may make the transplant work better and keep cancer cells from coming back. PURPOSE: This phase I trial is studying the side effects and best dose of donor natural kill cells in preventing relapse or graft failure in patients who have undergone donor bone marrow transplant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started May 2007

Shorter than P25 for phase_1 cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 26, 2013

Status Verified

January 1, 2008

Enrollment Period

1.6 years

First QC Date

December 6, 2007

Last Update Submit

March 25, 2013

Conditions

Cancer

Keywords

adult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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)accelerated phase chronic myelogenous leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negativeblastic phase chronic myelogenous leukemiachildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchronic eosinophilic leukemiaprimary myelofibrosischronic myelomonocytic leukemiachronic neutrophilic leukemiachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromesdisseminated neuroblastomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuejuvenile myelomonocytic leukemiamyelodysplastic/myeloproliferative neoplasm, unclassifiablenodal marginal zone B-cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomahigh risk metastatic gestational trophoblastic tumorpreviously treated childhood rhabdomyosarcomapreviously treated myelodysplastic syndromesrecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent/refractory childhood Hodgkin lymphomarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood rhabdomyosarcomarecurrent childhood small noncleaved cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomarecurrent mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent marginal zone lymphomasplenic marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomarecurrent neuroblastomarecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorrecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomarecurrent malignant testicular germ cell tumorstage III malignant testicular germ cell tumorchildhood malignant ovarian germ cell tumorchildhood malignant testicular germ cell tumorrecurrent Wilms tumor and other childhood kidney tumorsrefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarefractory multiple myelomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromesstage I multiple myelomastage II multiple myelomastage II ovarian epithelial cancerstage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiastage III ovarian epithelial cancerstage III multiple myelomastage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerstage III adult Hodgkin lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose of donor natural killer (NK) cells

  • Safety

  • Effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor bone marrow transplantation

Interventions

therapeutic allogeneic lymphocytesBIOLOGICAL

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Has undergone HLA-haploidentical familial donor bone marrow transplantation within the past 4-6 weeks * No manifestations of acute graft-vs-host disease at the time of planned donor natural killer cell infusion PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Bilirubin \< 2.0 mg/dL * AST \< 3 times upper limit of normal * Creatinine \< 2.0 mg/dL * Ejection fraction \> 40% on MUGA scan PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Korea Research Institute of Bioscience and Biotechnology

Dajeon, 305-806, South Korea

Location

Asan Medical Center - University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

NeoplasmsCongenital AbnormalitiesLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelomonocytic, JuvenileMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZonePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticRecurrenceDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, FollicularLymphoma, Mantle-CellNeuroblastomaCarcinoma, Ovarian EpithelialLeukemia, Lymphocytic, Chronic, B-CellTesticular NeoplasmsOvarian Germ Cell CancerWilms TumorLeukemia, Hairy CellMultiple MyelomaBreast Neoplasms

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyelodysplastic-Myeloproliferative DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinomaOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersLeukemia, B-CellGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsNeoplastic Syndromes, HereditaryKidney DiseasesUrologic DiseasesGenetic Diseases, InbornNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kyoo H. Lee, MD

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 7, 2007

Study Start

May 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 26, 2013

Record last verified: 2008-01

Locations

KR(2)