NCT00410657

Brief Summary

RATIONALE: Alemtuzumab and glucocorticoids, such as prednisone or methylprednisolone, may be an effective treatment for acute graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with glucocorticoids works in treating newly diagnosed acute graft-versus-host disease in patients who have undergone donor stem cell transplant.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for phase_2 breast-cancer

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

July 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
Last Updated

May 14, 2010

Status Verified

May 1, 2010

Enrollment Period

4 months

First QC Date

December 11, 2006

Last Update Submit

May 12, 2010

Conditions

Breast CancerChronic Myeloproliferative DisordersGestational Trophoblastic TumorGraft Versus Host DiseaseLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative DiseasesNeuroblastomaOvarian CancerTesticular Germ Cell Tumor

Keywords

graft versus host diseaseadult 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 leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionatypical chronic myeloid leukemiablastic phase chronic myelogenous leukemiachildhood chronic myelogenous leukemiachronic phase chronic myelogenous leukemiachronic eosinophilic leukemiachronic idiopathic myelofibrosischronic myelomonocytic leukemiachronic neutrophilic leukemiade novo myelodysplastic syndromesdisseminated neuroblastomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuejuvenile myelomonocytic leukemiamyelodysplastic/myeloproliferative disease, unclassifiablenodal marginal zone B-cell lymphomanoncontiguous stage II adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomastage III grade 1 follicular lymphomastage IV grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomanoncontiguous stage II marginal zone lymphomasplenic marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomapoor prognosis metastatic gestational trophoblastic tumorstage I multiple myelomastage II multiple myelomastage III multiple myelomastage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial canceraggressive, noncontiguous stage II adult non-Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiastage III malignant testicular germ cell tumorstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerchildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with methylprednisolone (MP)-equivalent glucocorticoid doses ≤ 0.75 mg/kg on day 28 after starting therapy for graft-versus-host disease (GVHD)

Secondary Outcomes (10)

  • Total cumulative dose of MP-equivalent treatment during the first 8 weeks after study entry

  • Proportion of patients with complete response, measured weekly through day 56

  • Incidence of secondary systemic therapy for acute GVHD

  • Cumulative acute GVHD activity index score at day 56

  • Incidence of chronic GVHD at 1 year

  • +5 more secondary outcomes

Interventions

alemtuzumabBIOLOGICAL
methylprednisoloneDRUG
prednisoneDRUG
flow cytometryOTHER
immunologic techniqueOTHER
pharmacological studyOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Newly diagnosed acute graft-versus-host disease (GVHD) * Grade IIB-IV disease * Requires glucocorticoids for treatment of GVHD, as indicated by 1 of the following: * Initial treatment with prednisone or methylprednisolone at 2 mg/kg is indicated (in the judgement of the attending physician) by any of the following: * Severity of GVHD requires hospitalization * GVHD manifestations include symptoms other than anorexia, nausea, and vomiting * GVHD begins within 2-3 weeks after hematopoietic stem cell transplantation (HSCT) * GVHD manifestations progress rapidly from 1 day to the next before treatment * Initial treatment with prednisone or methylprednisolone at 1 mg/kg did not produce adequate clinical improvement within the first 4 days (in the judgement of the attending physician) * Has undergone allogeneic HSCT with myeloablative conditioning * No nonmyeloablative conditioning or autologous HSCT * No primary treatment of acute GVHD with methylprednisolone at any of the following doses: * More than 2 mg/kg/day at any time * 2 mg/kg/day for \> 72 hours * 1 mg/kg/day for \> 96 hours * No presence of distinctive or diagnostic manifestations of chronic GVHD * No relapsed, refractory, or secondary malignancy PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 20-100% OR Lanksy PS 20-100% * Life expectancy ≥ 1 month * Absolute neutrophil count ≥ 500/mm\^3 * Negative pregnancy test * No Mini Mental State Exam score \< 24/30 or confusion (for patients \> 12 years of age) * No history of type I hypersensitivity reaction to alemtuzumab or any of its components * No increasing levels of viremia by serial quantitative viral plasma polymerase chain reaction assays * No invasive viral or fungal disease that does not respond to appropriate antiviral or antifungal medications PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No systemic immunosuppression tapered or stopped for treatment of leukemic relapse or minimal residual disease

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

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsMyeloproliferative DisordersGestational Trophoblastic DiseaseGraft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeuroblastomaOvarian NeoplasmsTesticular Germ Cell TumorCongenital AbnormalitiesLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisLeukemia, Myeloid, Chronic-PhasePdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myelomonocytic, JuvenileLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellCarcinoma, Ovarian EpithelialAggressionHodgkin DiseaseTesticular Neoplasms

Interventions

AlemtuzumabMethylprednisolonePrednisoneFlow CytometryImmunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesTrophoblastic NeoplasmsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypePregnancy Complications, NeoplasticPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesImmune System DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemia, B-CellCarcinomaAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial BehaviorGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Paul Carpenter, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 13, 2006

Study Start

July 1, 2006

Primary Completion

November 1, 2006

Last Updated

May 14, 2010

Record last verified: 2010-05

Locations

US(1)