NCT00611351

Brief Summary

RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2005

Typical duration for phase_2

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

June 7, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2008

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

April 3, 2018

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2.7 years

First QC Date

February 7, 2008

Results QC Date

March 5, 2018

Last Update Submit

October 5, 2023

Conditions

Graft Versus Host DiseaseLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative DiseasesSecondary Myelofibrosis

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)recurrent adult acute myeloid leukemiauntreated adult acute myeloid leukemiauntreated adult acute lymphoblastic leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiastage III multiple myelomarefractory multiple myelomade novo myelodysplastic syndromesmyelodysplastic/myeloproliferative disease, unclassifiablepreviously treated myelodysplastic syndromessecondary myelodysplastic syndromessecondary myelofibrosissecondary 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 adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent adult acute lymphoblastic leukemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult nasal type extranodal NK/T-cell lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic 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 lymphomastage III mantle cell lymphomastage IV mantle cell lymphomastage III marginal zone lymphomastage IV marginal zone lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionatypical chronic myeloid leukemianoncontiguous 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 lymphomarefractory hairy cell leukemiastage I multiple myelomastage II multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Transplantation-related Mortality at 100 Days Post-transplantation

    at the 100 days post-transplant

Secondary Outcomes (3)

  • Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)

    at day 100 post transplantation

  • Overall Survival

    2 years post transplant

  • Event-free Survival

    2 years post transplant

Study Arms (1)

Unrelated Donor Allogeneic

EXPERIMENTAL

Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.

Biological: anti-thymocyte globulinDrug: busulfanDrug: cyclophosphamideDrug: mycophenolate mofetilDrug: tacrolimusGenetic: polymerase chain reactionGenetic: polymorphism analysisOther: flow cytometryOther: laboratory biomarker analysisOther: pharmacogenomic studiesOther: pharmacological studyProcedure: allogeneic bone marrow transplantationProcedure: allogeneic hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantation

Interventions

anti-thymocyte globulinBIOLOGICAL
Also known as: immunosuppressant
Unrelated Donor Allogeneic
busulfanDRUG
Also known as: Busulfex, Myleran
Unrelated Donor Allogeneic
cyclophosphamideDRUG
Also known as: cytophosphane
Unrelated Donor Allogeneic
mycophenolate mofetilDRUG
Also known as: CellCept
Unrelated Donor Allogeneic
tacrolimusDRUG
Also known as: Protopic, Envarsus XR, Astagraf XL
Unrelated Donor Allogeneic
polymerase chain reactionGENETIC
Unrelated Donor Allogeneic
polymorphism analysisGENETIC
Unrelated Donor Allogeneic
flow cytometryOTHER
Unrelated Donor Allogeneic
laboratory biomarker analysisOTHER
Unrelated Donor Allogeneic
pharmacogenomic studiesOTHER
Unrelated Donor Allogeneic
pharmacological studyOTHER
Unrelated Donor Allogeneic
allogeneic bone marrow transplantationPROCEDURE
Unrelated Donor Allogeneic
allogeneic hematopoietic stem cell transplantationPROCEDURE
Unrelated Donor Allogeneic
peripheral blood stem cell transplantationPROCEDURE
Unrelated Donor Allogeneic

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed diagnosis of 1 of the following:
  • Acute myeloid leukemia
  • Acute lymphocytic leukemia
  • Chronic myelogenous leukemia beyond first chronic phase (i.e., 2nd chronic phase, accelerated phase, or blast crisis)
  • Multiple myeloma
  • Myelodysplastic syndromes
  • Malignant lymphoma
  • Myelofibrosis
  • Requirement for myeloablative conditioning regimen confirmed by attending physician
  • Available donor must meet the following criteria:
  • HLA phenotypically identical unrelated donor by low, intermediate, or high resolution for HLA class I antigens, and by high resolution for HLA class II antigens
  • Matched at the A, B, and DRβ1 loci
  • Single HLA-A or HLA-B antigen mismatch allowed
  • Meets all National Marrow Donor Program or foreign registry criteria for allogeneic bone marrow/stem cell donors
  • Peripheral blood stem cells are the preferred product on this study but bone marrow is allowed
  • +6 more criteria

You may not qualify if:

  • No active uncontrolled infection
  • Not pregnant or nursing/negative pregnancy test
  • No HIV infection
  • No chronic active hepatitis B or C or evidence of cirrhosis on liver biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Graft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesCongenital AbnormalitiesLeukemia, Myeloid, AcuteLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhaseMyeloproliferative DisordersBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Extranodal NK-T-CellLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLeukemia, Hairy Cell

Interventions

Antilymphocyte SerumImmunosuppressive AgentsBusulfanCyclophosphamideMycophenolic AcidTacrolimusPolymerase Chain ReactionAmplified Fragment Length Polymorphism AnalysisFlow CytometryPharmacogenomic TestingPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLymphoma, T-CellLeukemia, B-Cell

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesImmunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsMacrolidesLactonesNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesDNA FingerprintingCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalGenetic TestingGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health ServicesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Lori Maness-Harris
Organization
University of Nebraska Medical Center
lmaness@unmc.edu
402-559-3848

Study Officials

  • Marcel Devetten, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2008

First Posted

February 8, 2008

Study Start

June 7, 2005

Primary Completion

February 1, 2008

Study Completion

September 17, 2008

Last Updated

October 23, 2023

Results First Posted

April 3, 2018

Record last verified: 2023-10

Locations

US(1)