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

Not Applicable

Completed

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

• Registration Number: NCT00333190
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-05-25
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Primary Completion: 2007-03
• Study Completion: 2009-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To assess sustained engraftment	2 years
to determine the incidence of GVHD	2 years
to assess disease relapse.	2 years

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States