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

NCT ID: NCT00333190

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-03-31

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.

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.

Conditions

Hematologic Malignancy; AML; ALL; CML; Multiple Myeloma; NHL; Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

CD+8 T cell depletion

CD8 depleted product Given through central line after treatment with fludarabine and busulfex intravenously for 4 days

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Vincent T. Ho, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincent T. Ho, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

05-151

Identifier Type: -

Identifier Source: org_study_id