Evaluation of Fostamatinib in Patients With cGVHD After Allogeneic Stem Cell Transplant

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Stefanie Sarantopoulos, MD, PhD.
Study ID
NCT02611063
Phase
PHASE1
Status
Completed

Conditions

  • Hematological Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate whether fostamatinib, a drug that blocks activated B cells will be effective in preventing and treating chronic graft vs host disease (cGVHD) after allogeneic stem cell transplant. Activated B cells may play a role in development of cGVHD. Inhibiting the B cell activation using fostamatinib after allogeneic stem cell transplant may prevent the development of cGVHD.

Key Dates

Start date
Jan 31, 2016
Status verified
Mar 2023
Primary completion
Feb 28, 2021
Completion
Feb 22, 2022

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: fostamatinib
    Subjects will receive fostamatinib 100 mg qd, 150 mg qd, or 100 mg bid with dosage determined by the modified continual reassessment method. The treatment period begins at baseline 90 days after transplant and continues for up to 1 year after transplant. In patients with steroid-refractory cGVHD who are also included on this study, these subjects also receive fostamatinib 100mg qd, 150mg qd, or 100mg bid dosage determined by the modified continual reassessment method.

Primary Outcome Measure

Evaluate maximum tolerated dose of fostamatinib delivered following allogenic transplantation [ Time Frame: day 60 after fostamatinib initiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University of MedicineDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University of Medicine· Durham, NC

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