CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00333190

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	Procedure: CD+8 T cell depletion

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	CD8+ T Cell Depletion as Graft Versus Host Disease Prophylaxis After HLA-Matched Unrelated Donor Non-Myeloablative Peripheral Blood Stem Cell Transplantation

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 ]

Estimated 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:

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

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:	Dana-Farber Cancer Institute ( Vincent T. Ho, MD )
Study ID Numbers:	05-151
Study First Received:	May 25, 2006
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00333190 History of Changes
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

Study placed in the following topic categories:

Immunoproliferative Disorders
Hematologic Neoplasms
Hodgkin Lymphoma, Adult
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases
Hodgkin's Disease
Paraproteinemias
Fludarabine monophosphate
Hemostatic Disorders
Homologous Wasting Disease

Multiple Myeloma
Graft Versus Host Disease
Lymphatic Diseases
Hemorrhagic Disorders
Busulfan
Graft vs Host Disease
Fludarabine
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Hematologic Neoplasms
Immune System Diseases
Hematologic Diseases
Blood Protein Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma

Lymphatic Diseases
Neoplasms
Neoplasms by Site
Hemorrhagic Disorders
Graft vs Host Disease
Cardiovascular Diseases
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 06, 2009