NCT00521430

Brief Summary

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and methotrexate before and after transplant may stop this from happening. PURPOSE: This clinical trial is studying the side effects and how well donor stem cell transplant works when given after conditioning therapy in treating patients with hematologic cancer, recurrent or metastatic solid tumor, or other disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable leukemia

Timeline
Completed

Started Apr 2004

Typical duration for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 26, 2013

Status Verified

October 1, 2007

Enrollment Period

4.1 years

First QC Date

August 24, 2007

Last Update Submit

March 25, 2013

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesNonmalignant NeoplasmUnspecified Adult Solid Tumor, Protocol Specific

Keywords

recurrent childhood grade III lymphomatoid granulomatosischildhood diffuse large cell lymphomarecurrent childhood large cell lymphomachildhood immunoblastic large cell lymphomarecurrent childhood lymphoblastic lymphomachildhood nasal type extranodal NK/T-cell lymphomarecurrent childhood small noncleaved cell lymphomaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionaplastic anemiarecurrent childhood acute lymphoblastic leukemiachildhood acute lymphoblastic leukemia in remissionchildhood 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)refractory anemia with excess blasts in transformationrefractory anemia with excess blastsrefractory anemia with ringed sideroblastsrefractory anemiarefractory multiple myelomachronic myelomonocytic leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiarecurrent adult Hodgkin lymphomarecurrent adult T-cell leukemia/lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromeadult nasal type extranodal NK/T-cell lymphomaWaldenström macroglobulinemiarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I multiple myelomastage II multiple myelomastage III multiple myelomacutaneous B-cell non-Hodgkin lymphomaunspecified adult solid tumor, protocol specificchildhood chronic myelogenous leukemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiarecurrent/refractory childhood Hodgkin lymphomasecondary myelodysplastic syndromesde novo myelodysplastic syndromespreviously treated myelodysplastic syndromes

Outcome Measures

Primary Outcomes (5)

  • Engraftment (neutrophil, platelet, and red blood cells)

  • Frequency and kinetics of mixed chimerism as assessed by polymerase chain reaction

  • Frequency and severity of regimen-related toxicities

  • Frequency of acute and chronic graft-versus-host disease

  • Immune reconstitution

Secondary Outcomes (3)

  • Tumor response rate

  • Duration of tumor response

  • Survival

Interventions

anti-thymocyte globulinBIOLOGICAL
busulfanDRUG
cyclosporineDRUG
fludarabine phosphateDRUG
methotrexateDRUG
methylprednisoloneDRUG
allogeneic hematopoietic stem cell transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * High-risk acute leukemia, including any of the following: * Refractory acute leukemia * Acute leukemia beyond first remission * Acute leukemia in first remission with poor prognostic features (e.g., chromosomal changes suggesting poor prognosis) * Chronic myelogenous leukemia in second chronic, accelerated, or blastic phase * Severe aplastic anemia that is not responsive to immunosuppressive therapy * Myelodysplastic syndromes, including any of the following: * Refractory anemia (RA) or RA with ringed sideroblasts with severe cytopenia * RA with excess blasts (RAEB) * RAEB in transformation * Chronic myelomonocytic leukemia * Refractory or relapsed non-Hodgkin or Hodgkin lymphoma * Multiple myeloma * Biopsy proven measurable solid tumor meeting 1 of the following criteria: * Recurrent disease after primary treatment and deemed incurable to standard treatment * Metastatic disease for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists * Must have a related HLA-haploidentical mismatched (3/6 or fewer loci) donor available 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% by MUGA 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 (1)

Asan Medical Center - University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28.

    PMID: 21715313RESULT

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesNeoplasmsLymphoma, Large B-Cell, DiffuseDendritic Cell Sarcoma, InterdigitatingLymphoma, Extranodal NK-T-CellBurkitt LymphomaAnemia, AplasticPrecursor Cell Lymphoblastic Leukemia-LymphomaCongenital AbnormalitiesAnemia, Refractory, with Excess of BlastsAnemia, RefractoryLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhaseHodgkin DiseasePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeWaldenstrom MacroglobulinemiaLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcuteRecurrence

Interventions

Antilymphocyte SerumBusulfanCyclosporinefludarabine phosphateMethotrexateMethylprednisolonePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesLymphoma, B-CellHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsAnemiaBone Marrow Failure DisordersLeukemia, LymphoidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidMyelodysplastic-Myeloproliferative DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphadenopathyLeukemia, B-Cell

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Kyoo H. Lee, MD

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

April 1, 2004

Primary Completion

May 1, 2008

Study Completion

September 1, 2008

Last Updated

March 26, 2013

Record last verified: 2007-10

Locations

KR(1)