CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Vincent T. Ho, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00333190
First received: May 25, 2006
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Hematologic Malignancy
AML
ALL
CML
Multiple Myeloma
NHL
Hodgkin's Lymphoma
Device: CD+8 T cell depletion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CD8+ T Cell Depletion as Graft Versus Host Disease Prophylaxis After HLA-Matched Unrelated Donor Non-myeloablative Peripheral Blood Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To assess the initial engraftment of HLA matched unrelated donor mobilized peripheral blood stem cells depleted of CD+8 cells. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess sustained engraftment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • to determine the incidence of GVHD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • to assess disease relapse. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2005
Study Completion Date: March 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CD+8 T cell depletion
    CD8 depleted product Given through central line after treatment with fludarabine and busulfex intravenously for 4 days
Detailed Description:
  • The patient will be admitted to the hospital once a good donor is found for chemotherapy and stem cell transplant. The patient will remain in the hospital for 8 days and will receive two chemotherapy drugs (fludarabine and Busulfex) intravenously once each day for 4 days.
  • On the third day after the patient has finished chemotherapy, the donor cells should arrive at Dana-Farber Cancer Institute and the lab will remove CD8 cells. Then the product will be given to the patient through a central line. If there are not enough stem cells in the donor product, then the CD8 cells will not be taken out, and the patient will get the whole product.
  • Just before and after the transplant, the patient will also take tacrolimus and methotrexate to help prevent GVHD. Tacrolimus is a pill that will be taken orally two times a day. Methotrexate is a chemotherapy drug that is given intravenously on days 1, 3 and 6 after the transplant. In addition to the these drugs, participants will also take antibiotics to prevent infection and Filgrastim (G-CSF, neupogen) until their white blood cell counts are better.
  • After the stem cell infusion, check-ups and blood tests will be performed at least once a week for 1 month. At about one month, a bone marrow biopsy to look for the donor's cells in the participants bone marrow will be performed. After the 1-month evaluation, the patient will be seen at least every 2 weeks with another bone marrow biopsy at 3-4 months after the transplant.
  • After the patient is past 100 days since transplant, they will be followed in the clinic and have blood work done at least once a month until 6 months post transplant.
  • The trial will end at 6 months after the transplant, but patients will be tracked for the rest of their life to look at long-term effects of this transplant.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333190

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Vincent T. Ho, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Vincent T. Ho, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00333190     History of Changes
Other Study ID Numbers: 05-151
Study First Received: May 25, 2006
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
stem cell transplant
graft versus host disease
GVHD
CD+8 T cell depletion

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Hodgkin Disease
Graft vs Host Disease
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphoma
Lymphatic Diseases

ClinicalTrials.gov processed this record on October 16, 2014