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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01012492
Other study ID # IRB00024488
Secondary ID Abatacept
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2009
Est. completion date January 2013

Study information

Verified date October 2019
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to determine the safety and tolerability when adding abatacept to acute Graft versus Host Disease in transplants for malignant diseases using unrelated donor bone marrow or peripheral blood stem cell grafts.


Description:

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Study Design


Related Conditions & MeSH terms

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Intervention

Drug:
Abatacept
Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.

Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

Koura DT, Horan JT, Langston AA, Qayed M, Mehta A, Khoury HJ, Harvey RD, Suessmuth Y, Couture C, Carr J, Grizzle A, Johnson HR, Cheeseman JA, Conger JA, Robertson J, Stempora L, Johnson BE, Garrett A, Kirk AD, Larsen CP, Waller EK, Kean LS. In vivo T cell — View Citation

Suessmuth Y, Mukherjee R, Watkins B, Koura DT, Finstermeier K, Desmarais C, Stempora L, Horan JT, Langston A, Qayed M, Khoury HJ, Grizzle A, Cheeseman JA, Conger JA, Robertson J, Garrett A, Kirk AD, Waller EK, Blazar BR, Mehta AK, Robins HS, Kean LS. CMV — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Grade III-IV Acute GVHD by Day 100. Grade III-IV Acute GVHD by Day 100. The incidence of Gr III-IV acute GVHD was measured by the modified Glucksburg scale. Day 100 post-transplant
Secondary Percentage of Participants With Grades III-IV Acute GVHD at 2 Years The rates of Grades III-IV acute GVHD were measured at 2 years according to standard Glucksberg criteria, which was 10%. 2 years after transplant
Secondary Hematologic and Immunologic Reconstitution Flow cytometric analysis of CD4 t-cell t-cell reconstitution was performed at day +100 post-transplant. Day +100 post-transplant
Secondary Protective Immunity Percent of CMV virus binding CD8+ t-cells at day +365 post-transplant Day +365 post-transplant
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