NCT00005988

Brief Summary

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment of the donor bone marrow with the patient's white blood cells and a monoclonal antibody may prevent this from happening. PURPOSE: Phase I trial to study the effectiveness of bone marrow transplantation with specially treated bone marrow in treating patients who have hematologic cancer that has not responded to previous therapy.

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_1

Timeline
Completed

Started Feb 2000

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

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

February 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2001

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2002

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

May 3, 2004

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

July 5, 2000

Last Update Submit

March 30, 2017

Conditions

Graft Versus Host DiseaseLeukemiaLymphomaMyelodysplastic SyndromesMyeloma

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomarefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiachildhood diffuse large cell lymphomachildhood immunoblastic large cell lymphomaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionrecurrent/refractory childhood Hodgkin lymphomastage I grade 3 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I adult Burkitt lymphomachronic myelomonocytic leukemiastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesgraft versus host diseasestage I childhood small noncleaved cell lymphomastage I childhood large cell lymphomastage II childhood small noncleaved cell lymphomastage II childhood large cell lymphomastage III childhood small noncleaved cell lymphomastage III childhood large cell lymphomastage IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomarefractory cytopenia with multilineage dysplasiachildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Incidence of primary graft failure

    up to 30 days post-transplant

Secondary Outcomes (3)

  • Incidence of hyperacute GVHD

    up to 100 days post-transplant

  • Incidence of Grade D acute GVHD

    up to 50 days post-transplant

  • Incidence of adverse events

    up to 100 days post-transplant

Study Arms (1)

in vitro-treated bone marrow transplantation

EXPERIMENTAL

* Donor bone marrow will be harvested on Day -2 * Bone Marrow incubated with irradiated recipient cells and anti-B7.1 and anti-B7.2 for 36 hours. * Bone marrow will be infused intravenously * Cyclophosphamide will be administered IV once daily * Total Body Irradiation (TBI) will be delivered per institutional practice * Methylprednisolone will be administered IV as 4 doses separated by 12 hours,

Drug: cyclophosphamideDrug: cyclosporineDrug: leucovorin calciumDrug: methotrexateDrug: methylprednisoloneProcedure: in vitro-treated bone marrow transplantationRadiation: radiation therapy

Interventions

cyclophosphamideDRUG
in vitro-treated bone marrow transplantation
cyclosporineDRUG
in vitro-treated bone marrow transplantation
leucovorin calciumDRUG
in vitro-treated bone marrow transplantation
methotrexateDRUG
in vitro-treated bone marrow transplantation
methylprednisoloneDRUG
in vitro-treated bone marrow transplantation
in vitro-treated bone marrow transplantationPROCEDURE
in vitro-treated bone marrow transplantation
radiation therapyRADIATION
in vitro-treated bone marrow transplantation

Eligibility Criteria

AgeUp to 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age ≤40 years.
  • Diagnoses-patients with the following hematologic malignancies and bone marrow failure syndromes:
  • Acute myelogenous leukemia-induction failure, relapse, second or greater complete remission (CR)
  • Acute lymphocytic leukemia-induction failure, relapse, second or greater CR, first CR with t(9;22), t(8;14), or t(4;11)
  • Non-Hodgkin's lymphoma (intermediate or high grade) which has failed to achieve CR with at least two induction regimens, relapse, second or greater CR
  • Multiple myeloma with poor prognostic features (elevated 0-2 microglobulin or high labeling index)
  • Hodgkin's disease in relapse or which fails to achieve CR after two chemotherapy regimens
  • Congenital or acquired bone marrow failure - poorly responsive to or intolerant of current therapy
  • Myelodysplastic syndrome of all subtypes except refractory anemia (RA)
  • Patient has a haploidentical family member that meets medical criteria for donation.
  • Eligibility for other transplant types:
  • Patient considered likely to have clinical deterioration and rapid disease progression during an unrelated donor search, or
  • Patient who has already had an unproductive donor search or
  • Patient ineligible for or has refused autologous transplant
  • Adequate renal and hepatic function for age:
  • +11 more criteria

You may not qualify if:

  • Eligibility for other transplant types:
  • Patient has family donor who is matched or single antigen mismatched at HLA-A, HLA-B, HLA-DR, and HLA-DQ. Donorrecipient matching must be evaluated via both phenotype and genotype.
  • Patient has available unrelated donor who is matched at HLA-A, HLA-B, and HLA-DR. Donor-recipient matching must be evaluated via both phenotype and genotype.
  • Active uncontrolled infection (continued positive blood or soft tissue cultures despite appropriate antibiotic treatment)
  • Positive 13-HCG in a female of childbearing potential
  • Evidence of HIV infection or known HIV positive serology
  • Any prior bone marrow transplant
  • Patients with Fanconi's anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Davies JK, Gribben JG, Brennan LL, Yuk D, Nadler LM, Guinan EC. Outcome of alloanergized haploidentical bone marrow transplantation after ex vivo costimulatory blockade: results of 2 phase 1 studies. Blood. 2008 Sep 15;112(6):2232-41. doi: 10.1182/blood-2008-03-143636. Epub 2008 Jul 10.

    PMID: 18617635BACKGROUND

MeSH Terms

Conditions

Graft vs Host DiseaseLeukemiaLymphomaMyelodysplastic SyndromesNeoplasms, Plasma CellPrecursor Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseMultiple MyelomaLeukemia, Myeloid, AcuteLymphoma, Large B-Cell, DiffuseRecurrenceLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLeukemia, Myelomonocytic, ChronicDendritic Cell Sarcoma, Interdigitating

Interventions

CyclophosphamideCyclosporineLeucovorinMethotrexateMethylprednisoloneRadiotherapy

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersBone Marrow DiseasesLeukemia, LymphoidHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, MyeloidLymphoma, B-CellDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsMyelodysplastic-Myeloproliferative DiseasesChronic DiseaseHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesAminopterinPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsTherapeutics

Study Officials

  • Eva Guinan, MD

    Dana-Farber Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2000

First Posted

May 3, 2004

Study Start

February 1, 2000

Primary Completion

June 16, 2001

Study Completion

March 8, 2002

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)