- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00333190
CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation
March 15, 2012 updated by: Vincent T. Ho, MD, Dana-Farber Cancer Institute
CD8+ T Cell Depletion as Graft Versus Host Disease Prophylaxis After HLA-Matched Unrelated Donor Non-myeloablative Peripheral Blood Stem Cell Transplantation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the initial engraftment of HLA matched unrelated donor mobilized peripheral blood stem cells depleted of CD+8 cells.
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess sustained engraftment
Time Frame: 2 years
|
2 years
|
to determine the incidence of GVHD
Time Frame: 2 years
|
2 years
|
to assess disease relapse.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Vincent T. Ho, MD, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
May 25, 2006
First Submitted That Met QC Criteria
June 1, 2006
First Posted (Estimate)
June 2, 2006
Study Record Updates
Last Update Posted (Estimate)
March 16, 2012
Last Update Submitted That Met QC Criteria
March 15, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms by Site
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Hematologic Neoplasms
- Multiple Myeloma
Other Study ID Numbers
- 05-151
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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