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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00333190
Collaborator
Brigham and Women's Hospital (Other)
30
2
42
15
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CD+8 T cell depletion
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Mar 1, 2007
Actual Study Completion Date :
Mar 1, 2009

Outcome Measures

Primary Outcome Measures

  1. To assess the initial engraftment of HLA matched unrelated donor mobilized peripheral blood stem cells depleted of CD+8 cells. [2 years]

Secondary Outcome Measures

  1. To assess sustained engraftment [2 years]

  2. to determine the incidence of GVHD [2 years]

  3. to assess disease relapse. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115
2 Dana-Farber Cancer Institute 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vincent T. Ho, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00333190
Other Study ID Numbers:
  • 05-151
First Posted:
Jun 2, 2006
Last Update Posted:
Mar 16, 2012
Last Verified:
Mar 1, 2012
Keywords provided by Vincent T. Ho, MD, Principal Investigator, Dana-Farber Cancer Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2012