NCT00265837

Brief Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer and abnormal 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. Removing the T cells from the donor cells before transplant may stop this from happening. PURPOSE: This randomized phase III trial is studying donor bone marrow that is treated in the laboratory using two different devices to compare how well they work in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

4.7 years

First QC Date

December 14, 2005

Last Update Submit

April 16, 2014

Conditions

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

Keywords

graft versus host diseaseadult 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)recurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiachildhood acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiachildhood acute lymphoblastic leukemia in remissionrecurrent childhood acute lymphoblastic leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachildhood chronic myelogenous leukemiachronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromeschronic myelomonocytic leukemiajuvenile myelomonocytic leukemiaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiablePhiladelphia chromosome negative chronic myelogenous leukemiastage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myelomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal 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 lymphomarecurrent adult Hodgkin lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent/refractory childhood Hodgkin lymphomarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomasplenic marginal zone lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved 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 III marginal zone lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult immunoblastic large cell lymphomachildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Incidence of graft-vs-host disease or graft failure

Interventions

graft versus host disease prophylaxis/therapyBIOLOGICAL
allogeneic bone marrow transplantationPROCEDURE
in vitro-treated bone marrow 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 hematologic malignancies or genetic disorders: * Acute myeloid leukemia (AML), meeting 1 of the following criteria * Primary resistant disease * Disease in complete remission (CR) * Disease in first early relapse * Secondary AML arising out of myelodysplastic syndrome * Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria: * Primary resistant disease * Disease in CR * Disease in first early relapse * Chronic myelogenous leukemia * Myelodysplastic syndrome (MDS) * Chronic myelomonocytic leukemia * Philadelphia chromosome-negative myeloproliferative disorder * Multiple myeloma * Hodgkin's lymphoma * Non-Hodgkin's lymphoma * Genetic disorders or inborn errors of metabolism * Planning allogeneic bone marrow transplantation at the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Center * Must have an HLA-identical sibling donor by serologic or molecular typing of HLA class I antigens and molecular typing of HLA class II antigens PATIENT CHARACTERISTICS: Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * No prior red blood cell or platelet transfusion from the same donor Other * Concurrent participation in another clinical trial allowed

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

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Graft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesCongenital AbnormalitiesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelomonocytic, ChronicLeukemia, Myelomonocytic, JuvenileLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersHodgkin DiseaseLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticRecurrenceDendritic Cell Sarcoma, InterdigitatingLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Therapeutics

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, LymphoidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisLeukemia, B-Cell

Study Officials

  • Richard J. Jones, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 15, 2005

Study Start

December 1, 2002

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

US(1)