NCT00295997

Brief Summary

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well a donor stem cell transplant works in treating patients with hematologic cancer, metastatic kidney cancer, or aplastic anemia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

May 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
Last Updated

January 6, 2014

Status Verified

April 1, 2007

First QC Date

February 23, 2006

Last Update Submit

January 3, 2014

Conditions

Chronic Myeloproliferative DisordersKidney CancerLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

adult 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)accelerated phase chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionatypical chronic myeloid leukemia, BCR-ABL1 negativeblastic phase chronic myelogenous leukemiachildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood chronic myelogenous leukemiachronic eosinophilic leukemiaprimary myelofibrosischronic myelomonocytic leukemiachronic neutrophilic leukemiachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromesessential thrombocythemiajuvenile myelomonocytic leukemiamyelodysplastic/myeloproliferative neoplasm, unclassifiablepolycythemia verapreviously treated myelodysplastic syndromesrecurrent adult acute myeloid leukemiaprolymphocytic leukemiarecurrent adult Hodgkin lymphomarecurrent adult diffuse large cell 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 grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarefractory chronic lymphocytic leukemiarefractory multiple myelomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromesstage II multiple myelomastage III chronic lymphocytic leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III multiple myelomastage IV chronic lymphocytic leukemiastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomarecurrent renal cell cancerstage IV renal cell cancernoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomarecurrent adult acute lymphoblastic leukemiachildhood myelodysplastic syndromes

Interventions

anti-thymocyte globulinBIOLOGICAL
filgrastimBIOLOGICAL
graft-versus-tumor induction therapyBIOLOGICAL
therapeutic allogeneic lymphocytesBIOLOGICAL
busulfanDRUG
cyclophosphamideDRUG
fludarabine phosphateDRUG
methotrexateDRUG
mycophenolate mofetilDRUG
tacrolimusDRUG
allogeneic bone marrow transplantationPROCEDURE
nonmyeloablative allogeneic hematopoietic stem cell transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

AgeUp to 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Aplastic anemia not responsive to immunosuppressive therapy * Metastatic renal cell carcinoma * Hematologic malignancy, including any of the following: * Acute myeloid leukemia (AML)\* not curable with chemotherapy and meeting any of the following criteria: * AML with high-risk cytogenetic abnormalities (e.g., -7, -7q, -5, -5q, complex, Philadelphia chromosome-positive \[Ph+\]) * AML evolved from prior myelodysplasia * AML secondary to prior chemotherapy * Failed to achieve remission * In second or subsequent remission NOTE: \*Marrow blasts \< 10%- can be achieved by chemotherapy * Myelodysplasia\* with any of the following high-risk features: * Adverse cytogenetics (-7, 7q, -5, -5q, complex) * Excess blasts * Prior conversion to AML * Severe cytopenias with absolute neutrophil count \< 500/mm\^3 or platelet count \< 20,000/mm\^3 NOTE: \*Marrow blasts \< 10%- can be achieved by chemotherapy * Acute lymphoblastic leukemia (ALL)\* not curable with chemotherapy and meeting any of the following criteria: * High-risk cytogenetics (Ph+, 11q23 abnormalities, monosomy 7) * More than 1 induction course required to achieve remission * Failed to enter remission * In second or subsequent remission NOTE: \*Marrow blasts \< 10 % * Chronic lymphocytic leukemia (CLL) with high-risk features, including any of the following: * Refractory to initial or subsequent therapy * Progression after initial response to therapy * Prolymphocytic morphology * Follicular lymphoma with any of the following high-risk features: * Refractory to initial or subsequent therapy * Progression after response to initial therapy * Has ≥ 3 International Prognostic Index (IPI) risk factors * Multiple myeloma * Stage II-III disease confirmed at diagnosis or after initial progression * Other lymphoma that has failed to respond to primary therapy, progressed, or recurred after prior therapy, including any of the following: * Diffuse large cell lymphoma * Mantle cell lymphoma * Hodgkin's lymphoma * Myeloproliferative disease with evidence of disease acceleration, including any of the following: * Myelofibrosis * Polycythemia vera * Essential thrombocythemia * Chronic myeloid leukemia (CML) that failed to be controlled by imatinib mesylate * Disease must be stable or responding to therapy * No rapid progression of malignant disease * Expected time to disease progression \> 12 weeks * Not eligible for autologous stem cell transplantation * Matched unrelated donor available * 9/10 HLA matched, including HLA-A, -B, -C, -DR, and -DQ PATIENT CHARACTERISTICS: * Creatinine \< 2.0 mg/dL * Creatinine clearance \> 40 mL/min * Bilirubin \< 3 mg/dL * Elevated total bilirubin due to Gilbert's disease allowed if direct bilirubin is normal * AST \< 4 times upper limit of normal * Hepatitis C or B allowed provided bilirubin and AST are normal * Cardiac ejection fraction \> 30% * DLCO \> 40% of predicted * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled active infection requiring ongoing antibiotic treatment * No poor performance status * No poor organ function PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior stem cell or bone marrow transplantation allowed

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

Sponsors & Collaborators

Study Sites (2)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersKidney NeoplasmsLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesCongenital AbnormalitiesLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseThrombocythemia, EssentialLeukemia, Myelomonocytic, JuvenilePolycythemia VeraLeukemia, Myeloid, AcuteLeukemia, ProlymphocyticHodgkin DiseaseLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaRecurrenceDendritic Cell Sarcoma, InterdigitatingLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellCarcinoma, Renal Cell

Interventions

Antilymphocyte SerumFilgrastimBusulfanCyclophosphamidefludarabine phosphateMethotrexateMycophenolic AcidTacrolimusPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersBone Marrow NeoplasmsHematologic NeoplasmsLeukemia, LymphoidLymphoma, B-CellLymphoma, Non-HodgkinHistiocytic Disorders, MalignantHistiocytosisLeukemia, B-CellAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological FactorsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsMacrolidesLactonesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Charles A. Linker, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 24, 2006

Study Start

May 1, 2005

Last Updated

January 6, 2014

Record last verified: 2007-04

Locations

US(2)