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CD8+ T Cell Depletion as Graft Versus Host Disease Prophylaxis After HLA-Matched Unrelated Donor Non-myeloablative Peripheral Blood Stem Cell Transplantation

18 Years
Not Enrolling
Hematologic Malignancy, AML, ALL, CML, Multiple Myeloma, NHL, Hodgkin's Lymphoma

Thank you

Trial Information

CD8+ T Cell Depletion as Graft Versus Host Disease Prophylaxis After HLA-Matched Unrelated Donor Non-myeloablative Peripheral Blood Stem Cell Transplantation

- 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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Vincent T. Ho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

March 2009

Related Keywords:

  • Hematologic Malignancy
  • AML
  • ALL
  • CML
  • Multiple Myeloma
  • NHL
  • Hodgkin's Lymphoma
  • stem cell transplant
  • graft versus host disease
  • GVHD
  • CD+8 T cell depletion
  • Neoplasms
  • Graft vs Host Disease
  • Hodgkin Disease
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115