NCT00725062

Brief Summary

RATIONALE: A donor peripheral stem cell transplant helps stop the growth of cancer cells. When the healthy 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. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of donor T cells may helps stop the patient's immune system from rejecting the donor's stem cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of donor T cells in treating patients with high-risk hematologic cancer who are undergoing donor peripheral blood stem cell transplant. Note: Only Phase I portion of study was performed. Due to slow accrual, study was closed before Phase II portion of study.

Trial Health

57
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Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

July 29, 2008

Last Update Submit

November 27, 2017

Conditions

Graft Versus Host DiseaseLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

graft versus host diseaseadult acute lymphoblastic leukemia in remissionadult 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)chronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesstage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myelomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent adult acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarecurrent 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 grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of CD4+CD25+ cells/kg (phase I)

    Day 0 (48 hours post infusion)

  • Incidence of grade 3-5 infusional toxicity (phase II)

    Day 0 (48 hours post infusion)

Secondary Outcomes (5)

  • Cumulative incidence of grade II-IV acute graft-versus-host-disease (GVHD)

    Day 100 Post Infusion

  • Incidence of chronic graft-versus-host disease (GVHD)

    Month 6 Post Infusion

  • Incidence of Relapse

    Month 6 Post Infusion

  • Overall Survival

    Day 100 and 1 Year Post Infusion

  • Disease-free survival

    Day 100 and 1 Year Post Infusion

Study Arms (1)

Patients Receiving CD4+/CD25+ cells

EXPERIMENTAL

CD4+/CD25+ cells given intravenously over 15-60 minutes on Day -2 (prior to peripheral blood progenitor cell transplant)

Biological: CD4+CD25+ regulatory T cellsProcedure: allogeneic hematopoietic stem cell transplantation

Interventions

CD4+CD25+ regulatory T cellsBIOLOGICAL

Cohort 1 will receive 3 x 10\^6 CD4+CD25+ cells/kg, Cohort 2 will receive 1 x 10\^7 CD4+CD25+ cells/kg, Cohort 3 will receive 3 x 10\^7 CD4+CD25 cells/kg

Patients Receiving CD4+/CD25+ cells
allogeneic hematopoietic stem cell transplantationPROCEDURE

Occurs on Day 0 of study - HLA-identical sibling donor peripheral blood progenitor cell (PBPC) transplantation

Also known as: peripheral blood progenitor cell (PBPC) transplantation
Patients Receiving CD4+/CD25+ cells

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of a high-risk hematologic malignancy, including any of the following:
  • Acute lymphocytic leukemia
  • Acute myelocytic leukemia
  • Chronic myelogenous leukemia
  • Myelodysplastic syndrome
  • Non-Hodgkin lymphoma
  • Multiple myeloma
  • Meet eligibility criteria and co-enrolled in one of the following University of Minnesota protocols:
  • MT2001-02 consisting of myeloablative prep (cyclophosphamide and total body irradiation) followed by HLA-identical sibling peripheral blood progenitor cells (PBPC) transplantation
  • MT2001-10 consisting of nonmyeloablative prep (cyclophosphamide, fludarabine and total body irradiation) followed by HLA-identical sibling PBPC transplantation
  • Voluntarily written informed consent
  • Must have an HLA-identical sibling donor available, meeting the following criteria:
  • to 75 years of age, \>40 kg body weight and in good health
  • Matched to recipient for HLA-A, B,DRB1 identical sibling match to recipient
  • Must be able and willing to have a separate apheresis collection performed on day -21 for the purposes of this study (in addition to the apheresis required for the transplant protocol)
  • +1 more criteria

You may not qualify if:

  • Not pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Graft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesCongenital AbnormalitiesLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

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, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemia, B-Cell

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Margaret L. MacMillan, MD

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 30, 2008

Study Start

June 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

US(1)