NCT00333190

Brief Summary

The purpose of this trial is to determine if selectively removing only a small subset of T cells, called CD8+ T cells, is safe and if it can reduce the risk of graft versus host disease (GVHD) without losing the anti-cancer effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

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

September 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2006

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

1.5 years

First QC Date

May 25, 2006

Last Update Submit

March 15, 2012

Conditions

Hematologic MalignancyAMLALLCMLMultiple MyelomaNHLHodgkin's Lymphoma

Keywords

stem cell transplantgraft versus host diseaseGVHDCD+8 T cell depletion

Outcome Measures

Primary Outcomes (1)

  • To assess the initial engraftment of HLA matched unrelated donor mobilized peripheral blood stem cells depleted of CD+8 cells.

    2 years

Secondary Outcomes (3)

  • To assess sustained engraftment

    2 years

  • to determine the incidence of GVHD

    2 years

  • to assess disease relapse.

    2 years

Interventions

CD+8 T cell depletionDEVICE

CD8 depleted product Given through central line after treatment with fludarabine and busulfex intravenously for 4 days

Eligibility Criteria

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

You may qualify if:

  • Hematologic malignancies that are candidates for allogeneic non-myeloablative stem cell transplantation
  • AML or ALL in first or subsequent remission, or in resistant or untreated relapse with marrow blast \< 20% of cellularity
  • CML in first or subsequent chronic phase, or accelerated phase
  • Myelodysplastic syndrome with \< 20% marrow blasts
  • NHL or Hodgkin's lymphoma in second or greater remission, or partial remission after salvage therapy, and in patients with marrow involvement, \<20% involvement in BM
  • CLL RAI stage 2-4, which has progressed after initial fludarabine containing therapy, and BM involvement of \< 20%
  • Multiple myeloma stage II-III, in first or subsequent plateau phase with \<20% BM plasma cells
  • Available unrelated donor who is fully HLA matched at HLA-A,B,C and DRB1
  • Age 18 or greater
  • Performance status 0-2
  • Life expectancy of \> 100 days
  • No HLA-matched related donor available

You may not qualify if:

  • Myeloproliferative disorders other than CML
  • MDS with myeloproliferative features, or CMML
  • High grade Burkitts or Burkitts-like Non-Hodgkin's lymphoma
  • Prior allogeneic stem cell transplant
  • Active CNS involvement with disease
  • Uncontrolled infection
  • Pregnancy
  • Evidence of HIV infection
  • Heart failure uncontrolled my medications
  • Total bilirubin \> 2.0 mg/dl that is due to hepatocellular dysfunction
  • AST \> 2 x institutional upper limit of normal
  • Serum creatinine \> 2.0 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hematologic NeoplasmsMultiple MyelomaHodgkin DiseaseGraft vs Host Disease

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphomaLymphatic Diseases

Study Officials

  • Vincent T. Ho, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2006

First Posted

June 2, 2006

Study Start

September 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2009

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

US(2)